Neuro-Therapeutics Studies

1. Title: A Double—Blind, Placebo-Controlled,Safety, Efficacyand Dose Response Trial

of Three Intravenous Doses of BMS-204352 in Patients withAcute Stroke

Sponsor: Bristol-Myers SquibbDates of Participation: November 1998 to 2000

Summary/Objective:To determine the safety, efficacyand dose response of intravenous

BMS-204352 versus placebo in patients suspected infarction of the cerebral cortex.

Enrollment: 52

2. Title: MS Trac:A Registry of Multiple Sclerosis Treatmentand Care (phase IV).Sponsor: Biogen

1

Dates of Participation: July 1998 —- May 20011

Summary/Objective:To collect data on treatment patterns of relapsing MS and to

examine possible differences in treatment betweenMS specialists and otherphysicians.Enrollment: 22

3. Title: Keeper: Keppra Epilepsy Evaluation of Patient Time to Response (phase IV).Sponsor: UCB Pharma, Inc.Dates of Participation: May 2000 —- March 2001

Summary/Objective:To evaluate the tolerabilityof Levetiracetamby measuring safetyand seizure reduction effect.Enrollment: 4 of 4

4. Title: Randomized, Double—Blind, Placebo-ControlledTrialof Anakinra in the

Treatmentof Multiple Sclerosis (phase I/ll).Sponsor: AmgenDates of Participation: May 2000 — May 2001

Summary/Objective:To evaluate the effect of 24 weeks of treatment withanakinra

versus placebo based on active lesions on MRI.Enrollment: 1 patient; 11 screened

5. Title: An Open-label, Long-terrn Observational Study of the Safety and Tolerabilityof

Sumatriptan Nasal Spray in the Treatmentof Migraine in Adolescents (phase III).Sponsor: Glaxo Wellcome ‘

Dates of Participation: June 2000 — October 2001

Summary/Objective:To evaluate the safety and tolerabilityof Sumatriptan nasal spray

20mg in the acute treatment of migraine attacks in adolescents aged 12-17 over a periodof up to 12 months.Enrollment: 10 of 10

6. Title: Omap_atrilatCardiovascularTreatmentAssessment Versus Enalapril:OCTAVE

(phase III).Sponsor: Bristol-Myers SquibbDates of Participation: November2000 — March 2001

DS 2/08

Summary/Objective:To compare the reduction in systolic blood pressure at the

completion of 8 weeks of titrated therapy.Enrollment: 4

7. Title: Efficacyand Safety Study of the Oral Direct ThrombinInhibitorof H 376/95

Compared withDose-AdjustedWarfarin (Coumadin) in the Preventionof Stroke and

Systemic Embolic Events in Patients withAtrial Fibrillation:Sportif V (phase III).Sponsor: AstraZeneca

8

Dates of Participation: November2000 — April2003

Summary/Objective:To determine whether H 376/95 is non-inferior compared to dose-

adjustedwarfarin aiming for an INR 2.0 -3.0 for the prevention of all strokes (fatal and

non-fatal) and systemic embolic events in patients with chronic non—valvular AF.

Enrollment: 12

8. Title: A Randomized, Placebo-Controlled,Three TreatmentArm Study to Determine

the Safety and Efficacyof Argatroban Injection in Patients withAcute Ischemic Stroke:

ARGIS-1 (phase II).Sponsor: TexasBiotechnology CorporationDates of Participation: April2001 -— September2002

Summary/Objective:To determine the safety of Argatroban Injection in the treatment of

patients with acute ischemic stroke.Enrollment: 4

9. Title: Compliance Assessment for Reminyl: CARE Trial (phase IV)Sponsor: Janssen Pharmaceutica, Inc.

L

0

Dates of Participation: April2001 — March 2002

Summary/Objective:Demonstrate eqivalence of b.i.d. dosing of Reminyl compared to qh.s. dosing of vitamin E in regards to compliance.Enrollment: 4

10. Title: Prospective, Open-Label Tolerabilityand Safety Monitoring Study of

Novantrone in a Selected Cohort of Multiple Sclerosis Patients: RENEW (phase IV)Sponsor: Immunex CorporationDates of Participation: May 2001 — April2008

Summary/Objective:Collect data relevant to the tolerabilityofNovantrone therapy in

patients with MS using dosing and monitoring specified in package insert.

Enrollment: 12

11. Title: A Multicenter, Phase IV, Randomized, Open-Label Study to Compare the

Efficacyof Two Therapies (Acetaminophenand Prednisone in the Management of Flu-

Like Symptoms Associated withAVONEX® (Interferon beta—la) Treatment in Patients

withRelapsing Multiple SclerosisSponsor: Biogen, Inc.

'

Dates of Participation: May 2001 — April2002Summary/Objective:To compare the efficacyof prednisone and acetaminophen in the

managementof flu-likesymptoms over 12 weeks of treatment withAVONEX®.

DS 2/08

Enrollment: 1

12. Title: A randomized, multicenter, parallel group, open—label study comparing the

tolerabilityof Rebifinjection withand without the use of Rebijectw Mini in relapsingremitting MS patients.

2

Sponsor: SeronoDates of Participation: November2001 —- October 2002

Summary/Objective: To assess the effect of Rebijectm Mini on the safety and

tolerabilityof Rebiftherapy in Relapsing MS patients.Enrollment: 16

13. Title: A 12 week, double~blind, placebo controlled, parallel group study to assess the

efficacyand safety of Ropinirole in patients suffering from Restless Legs Syndrome(RLS) (phase III)Sponsor: GlaxoSmithKlineDates of Participation: March 2002 —- November2002

Summary/Objective:To compare the efficacy (1°) and safety, tolerabilityand beneficial

patient-reported outcomes (2°) of Ropinirole and placebo in the treatment of patients withRLS.Enrollment: 5

14. Title: Escitalopram effects on quality of lifeProtocol: SCT-MD-25Sponsor: Forest Laboratories, Inc.Dates of Participation: September2002 — November2002

Summary/Objective: An 8 week, phase IV study to assess Escitalopram (Lexapro) on

the quality of life in the treatment of patients withmajor depression.Enrollment: 5 of 5

15. Title: Double-blind, placebo-controlled,12-week parallel group study to evaluate

safety and efficacyof oral Fampridine-SR in subjects withmoderate to severe spasticityresulting from chronic, incomplete spinal cord injury (phase III)Protocol: SCI—F302Sponsor: Acorda Therapeutics, Inc.Dates of Participation: October 2002 ~ December3003Summary/Objective:To evaluate the clinical efficacy and safety of Fampridine-SR25

mg bid in the treatment of moderate to severe spasticity in subjects withchronic spinalcord injury who may or may not be treated with concurrent anti-spasticity medications.Enrollment: 9

16. Title: Open-Label extension of double—blind, placebo-controlled,parallel group studyto evaluate safety, tolerabilityand activityof oral Fampridine-SR in subjects with

chronic, incomplete spinal cord injury.Protocol: SCI—F300 EXTSponsor: Acorda Therapeutics, Inc.Dates of Participation: September2003 — September2004

DS 2/08

Summary/Objective: To evaluate the long term safety and tolerabilityof Fampridine-SRin subjects who participated in either SCI-F301 or SCl—F3 02.

Enrollment: 16

17. Title: A Multicenter, Randomized, Placebo-controlled,Double-blind, Parallel—groupTrialtoEvaluate Early Efficacyand Tolerabilityof Zolmitriptan (Zomig) Nasal Spray in

the Acute Treatmentof Adult Subjects withMigraine (phase III)Sponsor: AstraZenecaDates of Participation: November2002 — July 2003Summary/Objective:To evaluate early efficacy (as assessed by the percentage of

responders) of Zolmitriptan 5 mg nasal spray dose in the acute treatment of adult patientswithmigraine.Enrollment: 1 (3 week enrollment for our site—-3 screened)

18. Title: Double-blind RandomizedTrialof Cognitive Effects of LAMICTAL

(lamotrigine) versus Topiramate in Epilepsy (phase III)Sponsor: GlaxoSmithKlineDates of Participation: March 2003 — February 2005

Summary/Objective:To compare the cognitive effects of Topiramate and Lamictal as

adjunctivetherapy in adult patients withpartial seizures.Enrollment: 5

19. Title: Randomized, Double-Blind,Double-Dummy,Placebo-Controlled,Multi-Center TrialComparing the Effects of Orally Administered Xyrem® (sodium oxybate)and ModafinilwithPlacebo in the Treatmentof Daytime Sleepiness in Narcolepsy (phaseIII)Sponsor: Orphan MedicalDates of Participation: April2003 — August 2004

Summary/Objective:Efficacymeasures are daytime sleepiness as measured byobjective response in the Maintenance of Wakefulness Test at the end of the double-blindtreatment period as compared to placebo. :

Enrollment: 5

20. Title: Phase II, Randomized, Open—Label, Three-Arm Study Comparing Low-and

High-Dose CAMPATH®and High-Dose Rebif® in Patients withEarly,Active

Relapsing~Remitting Multiple SclerosisSponsor: IlexOncology/GenzymeDates of Participation: July 2003 —- June 2010

Summary/Objective:To reduce the time to sustained accumulationof disability(SAD)and reduce relapse rate.Enrollment: 4

DS 2/08

21. Title: Phase IV, Randomized, Open-Label Study Comparing Efficacy of Dose

Escalation of AVONEX plus Acetaminophen or Ibuprofen Therapy versus2

AcetaminophenAlone in the Managementof Flu—Lik_e Symptoms Associated with

AVONEXTherapy in Patients withRelapsing Multiple Sclerosis.

Sponsor: BiogenDates of Participation: May 2003 - April2005Summary/Objective: To compare the incidence of flu-likesymptoms using the

following side effect managementprotocols: acetaminophenalone, dose escalation of

AVONEX® in combinationwithacetaminophen,or dose escalation of AVONEX®with

ibuprofen.Enrollment: 4

22. Title: The EDSS Calculator for a PDA Using Palm OS or Windows CE OperatingSystem: A Reliabilityand Validity StudySponsor: TEVANeuroscienceDates of Participation: November2003 -— April2004

Summary’/Objective: Assess the extent to which the EDSS Calculator reflects the true

disabilitylevel of the subjects when compared to the pen and paper EDSS evaluation.Enrollment: 10 of 10

23. Title: A 12 Month, Open-Label, F lexible-Dosage (100 to 250mg/day) Study of the

Safety and Efficacyof CEP—l0953 in the Treatmentof Patients with Excessive SleepinessAssociated withNarcolepsy, Obstructive Sleep Apnea/HypopneaSyndrome, or ChronicShift Work Sleep DisorderSponsor: CephalonDates of Participation: April 2004 — October 2005Summary/Objective:To determine whether treatment with CEP-10953 is more effectivethan placebo treatment for patients withexcessive sleepiness associated withOSAHS bymeasuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) and byClinical Global Impression of Change.Enrollment: 2 (5 ready to enroll—enrollmentclosed)

24. Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Phase II Studyof Efficacyand Safety of SGS742 in Subjects withMildto Moderate Alzheimer’sDiseaseSponsor: Saegis Pharmaceuticals, Inc.Dates of Participation: April2004 — June 2005Summary/Objective:To determine the effect of SCS742 on memory and cognition in

older individuals withdiminished memory function who meet prospective criteria for

mild to moderate Alzheimer’s disease using the Alzheimer’s disease Assessment Scale

(ADAS-Cog)Enrollment: 4

DS 2/08

25. Title: A Randomized, Doubled-Blind, Placebo-ControlledStudy to Evaluate the

Safety, Tolerabilityand Efficacyof NBI-5788 in Patients with Relapsing MultipleSclerosis (phase II).Sponsor: NeurocrineDates of Participation: June 2004 - April2005Summary/Objective:To evaluate the safety and tolerabilityof NBI—5 788 administeredsubcutaneouslyfor nine months and to compare the effect ofNBI-5788 and placebotherapy on a summary change score for total Gd-enhancing cranial MRI lesions after ninemonths of treatment.Enrollment: l (7 screened)

26. Title: A 12-week, Double-Blind,Placebo Controlled, TwiceDailyDosing Study to

Assess the Efficacyand Safety of Ropinirole in Patients Suffering from Restless

Legs Syndrome (RLS) Requiring Extended TreatmentCoverage (phase Illb)013

Sponsor: GlaxoSmithKlineDates of Participation: October 2004 — August 2005Summary/Objective: To compare the efficacy and safety of Ropinirole and placebousing a twice dailydosing regimen in subjects with RLS requiring extended treatment

coverage. To assess the safety, tolerabilityand beneficialsubject-reported outcomes of

Ropinirole and placebo using twice dailydosing in the treatment of subjects with RLS

requiring extended treatment coverage.Enrollment: 6

27.Title: A Prospective, Multi—Center, Randomized, Open-Label Study withBlindedRaters to Evaluate the Effects of Immediate versus Delayed Switch to Stalevo® on MotorFunction and Quality of Life in Patients withParkinson’sDisease withEnd-of-Dose

Wearing Off (phase IV)Sponsor: NovartisDates of Participation: February 2005 -—- August 2007Summary/Objective: To assess changes in motor function and quality of life, in patientswithParkinson’sdisease withEODWO, by comparing the change from baseline to Week4 between immediate-switchand delayed-switch treatment arms.

Enrollment: 5

28.Title: A l2—Week, Double-Blind,Placebo Controlled, Parallel Group Study to Assessthe Efficacyand Safety of Ropinirole XR (Extended Release) in Patients withRestless

Legs SyndromeSponsor: GSKDates of Participation: April2005 — October 2005Summary/Objective: To compare the efficacyand safety of ropinirole XR and placeboin adult patients withRLS requiring early evening and nighttime coverage of RLS

symptomsEnrollment: 3 (enrollmentclosed 13 weeks early)

29.Title: A Short—Term(8-Week)Open-Label study, Followed by a Long-TermEvaluation, to Assess Patient-Reported Outcomes With ArmodafinilTreatment(150 to

DS 2/08

250 mg/day) for Excessive Sleepiness in Adults WithNarcolepsy or Obstructive SleepApnea/HypopneaSyndromeSponsor: CephalonDates of Participation: September2005 — October 2006Summary/Objective:To assess patient-reported outcomes witharmodafinil treatmentinterms of improvement in excessive sleepiness, satisfactionwith treatment, impact on

abilityto engage in life activities (i.e., daily or work and familyand/or social activities),and effects on fatigue.Enrollment: 11

30. Title: A Multicenter, Double-Blind,Randomized Conversion to MonotherapyComparison of Two Doses of Lamotrigine for the Treatmentof Partial SeizuresSponsor: GSKDates of Participation: April2006 - August 2007Summary/Objective:To demonstrate the efficacyof LTG at 250mg/d and 300mg/dcompared to pooled historic pseudoplacebo data. To evaluate the safety and tolerabilityof LTG extended release as monotherapy. A

Enrollment: 3 (enrollment requested 2)

31. Title: A Randomized, Double-Blind,Placebo—ControlledStudy to Assess the3 Efficacyand Safety of XPl3512 in Patients with Restless Leg Syndrome.

Sponsor: XenoportDates of Participation: May 2006 —- February 2008Summary/Objective: To compare the efficacyof XPl35l2 l200mg taken once dailyversus placebo for the treatment of RLS.Enrollment: 6

32. Title: A Phase IV randomized, double-blind,active and placebo-controlled,6-weektrial to investigate the efficacyand safety of a starting (and fixed) dose 0.25 mgpramipexole (Mirapex®) in patients with idiopathicRestless Legs SyndromeSponsor: Boehringer IngelheimDates of Participation: September2006 — October 2007Summary/Objective:To investigate the efficacyand safety of 0.25 mg dailypramipexole compared to a starting dose of 0.125 mg.Enrollment: 4

33. Title: Open-label, multicenter, single treatment effectiveness and safety study ofonce dailyAzi1ect® as mono» or adjuncttherapy in patients with idiopathicParkinson’sdisease (PD)Sponsor: TEVADates of Participation: November2006 — August 2007Summary/Objective:To characterizethe time to onset of symptomatic effect of Azilectas initial monotherapy_and_as adjuncttherapyand to characterizethe effectiveness ofAzilectbeyond the registration program by incorporating physicianand patient—ratedsatisfactionand ease-of—use scalesEnrollment: 6

DS 2/08

34. Title: A 24-monthdouble—blind, randomized, milticenter, placebo-controlled,parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fmgolimod(FTY720)administered orally once dailyversus placebo inpatients with relapsing-remitting multiple sclerosisSponsor: Novartis 5

Dates of Participation: November2006 -— August 2011

Summary/Objective:To compare fingolimod 1.25 mg and 0.5 mg withplacebo and to

demonstrate thatat least 1.25 mg fingolimod is superior to placebo in terms of annualizedrelapse rate for patients withRRMS treated for up to 24 months.Enrollment: 11

35..

Title: Extension to CFTY720D2309Sponsor: NovartisDates of Participation: February 2010 - presentSummary/Objective: to provide long-term safety, tolerabilityand efficacydata ofFTY720in patients with MS. All patients that have completed the 24-monthcore studymay enter the extension and wil be offered FTY720treatment until the drug becomesavailableof the marketor until development is terminated.Enrollment: 6

36. Title: ELN115727- 301: A phase III, milticenter, randomized, double—blind,placebo-controlled,parallel group, efficacy and safety trial of bapineuzumab (AAB-001,ELN1 15727) in patients withmild to moderate Alzheimer’s disease who are

Apolipoprotein E 64 carriers. 5

Sponsor: JanssenDates of Participation: February 2008 — presentSummary/Objective: To demonstrate an advantage of the efficacyof multiple doses of

intravenously (IV) administered bapineuzumab in patients withmild to moderate AD

over placebo.Enrollment: 3

37. Title: ELN1 l5727- 302: A phase III, milticenter, randomized, double—blind,placebo-controlled,parallel group, efficacy and safety trial of bapineuzumab (AAB-001,ELN115727) in patients withmild to moderate Alzheimer’s disease who are

Apolipoprotein E e4 carriers.Sponsor: JanssenDates of Participation: February 2008 - presentSummary/Objective:To demonstrate an advantage of the efficacyof multiple doses of

intravenously (IV) administered bapineuzumab in patients withmild to moderate ADover placebo.Enrollment: 6

38. Title: 351: A phase 3, extension, multicenter, double—blind, long term safety andtolerabilitytreatment trial of bapineuzumab in subjects withAlzheimer’s disease who

participated in study ELN1 15727-301 or 302Sponsor: Janssen

DS 2/08

Dates of Participation: August 2009 — November2012

Summary/Objective: to evaluate the long-term safety and efficacyof IV bapineuzumabin patients withADEnrollment: 6

39. Title: A phase 2, randomized, double-blind,placebo-controlled,parallel group,multi-center, biomarker,safety and pharmacokineticstudy of bapineuzumab (AAB-001)administered subcutaneouslyat monthly intervals in subjects withmild to moderateAlzheimer’s diseaseSponsor: Janssen Alzheimer ImunotherapyDates of Participation: November2010 -— April2013Summary/Objective: to assess the effect of bapineuzumab administered SC at monthlyintervals, at doses of 2,7, and 20 mg, compared to placebo on cerebral amyloid burden in

subj ects withmild to moderate ADEnrollment: 2

40. Title: CARE-MS II CAMMS324: A phase 3 randomized, rater-and dose-blindedstudy comparing two annual cycles of intravenous low- and high-dose Alemtuzumab to

three-timesweekly subcutaneous interferon Beta-la (Rebif) in patients withRRMS whohave relapsed on therapySponsor: Genzyme CorpDates of Participation: March 2008 ——— December2011

Summary/Objective: to compare the safety and efficacyof 2 annual cycles of 12mg/dayintravenous alemtuzumab to 3-times weekly SC interferon beta-la in patients withactive

relapsing-remitting MSEnrollment: 3

41. Title: CAMMSO3409: An extension protocol for MS patients who participated in

Genzyme-sponsored studies of AlemtuzumabSponsor: GenzymeDates of Participation: June 2011 - presentEnrollment: 2

42. Title: A phase 3, multicenter, randomized, placebo-controlled,double—blind twelve-month safety and efficacy study evaluating Dimebon in patients withmild to moderateAlzheimer’s disease on DonepezilSponsor: MedivationDates of Participation: March 2009 — March 2012Summary/Objective: to assess the efficacyof dimebon as compared to placebo on

ADAS-cog,ADL, CIBIC-plus and the safety and tolerabilityof 5mg and 20mg orallyTID over 52 weeks in patients withmild to moderate AD who are on a stable dose ofdonepezilEnrollment: 3

_

DS 2/08

43. Title: A randomized, double-blind,doub1e—dummy,parallel-group study to evaluate

the efficacyand safety of Ocrelizumab in comparison to Interferon beta la (Rebif) in

patients with relapsing multiple sclerosisSponsor: Roche, GenentechDates of Participation: August 2011-- presentSummary/Objective: to assess whether the efficacyof ocrelizumab 600 mg (given as

dual infusions of 300 mg ocrelizumab 14 days apart) intravenouslyevery 24 weeks is

superior to Rebifas measured by the annualized protocol—def1ned relapse rate by two

years in patients with relapsing MS.Enrollment: 3

44. Title: A randomized, double-blind,placebo-controlled,parallel-group, 18-month

safety and efficacystudy of Leuco-methylthioniniumbis in subjects withmildAlzheimer’s diseaseSponsor: TauRxDates of Participation: September2013 -- presentEnrollment: 5

45. Title: A Phase 3, 12-week, double-Blind,Placebo-controlled,Randomized,Multicenter Study to Evaluate the Efficacyof Oral lstradefylline 20 and 40 mg/day as

Treatment for Subjects withModerate to Severe Parkinson’sDisease

Sponsor: KyowaDates of Participation: March 2014 -- presentEnrollment: 6

46. Title: Efficacyand Safety of ADS-51 02 (AmantadineHCL) Extended Release

Capsules for the Treatmentof Levodopa Induced Dyskinesia in Parkinson’sDiseasePatients (Ease LID Study)Sponsor: AdamasPharmaceuticals, Inc.Dates of Participation: October 2014 -- presentEnrollment: 3

DS 2/O8

Neuro-Therapeutics Studies

1. Title: A Double-Blind,Placebo-Controlled,Safety, Efficacyand Dose Response Trial

of Three Intravenous Doses of BMS-204352 in Patients withAcute Stroke

Sponsor: Bristol-Myers SquibbDates of Participation: November 1998 to 2000

Summary/Objective:To determine the safety, efficacyand dose response of intravenousBMS-204352 versus placebo in patients suspected infarction of the cerebral cortex.

Enrollment: 5

2. Title: MS Trac:A Registry of Multiple Sclerosis Treatmentand Care (phase IV).Sponsor: Biogen

o Dates of Participation: July 1998 — May 2001

Summary/Objective:To collect data on treatment patterns of relapsing MS and to

examine possible differences in treatment between MS specialists and otherphysicians.Enrollment: 22

3. Title: Keeper: Keppra Epilepsy Evaluation of Patient Time to Response (phase IV).Sponsor: UCB Pharma, Inc.Dates of Participation: May 2000 — March 2001Summary/Objective:To evaluate the tolerabilityof Levetiracetamby measuring safetyand seizure reduction effect.Enrollment: 4 of 4

4. Title: Randomized, Doub1e—Blind, Placebo-ControlledTrialof Anakinra in theTreatmentof Multiple Sclerosis (phase I/ll).Sponsor: AmgenDates of Participation: May 2000 — May 2001Summary/Objective:To evaluate the effect of 24 weeks of treatment withanakinraversus placebo based on active lesions on MRI.Enrollment: 1 patient; 11 screened

5. Title: An Open-label, Long-term Observational Study of the Safety and Tolerabilityof

Sumatriptan Nasal Spray in the Treatmentof Migraine in Adolescents (phase III).Sponsor: Glaxo WellcomeDates of Participation: June 2000 — October2001Summary/Objective:To evaluate the safety and tolerabilityof Sumatriptan nasal spray20mg in the acute treatment of migraine attacks in adolescents aged 12-17 over a periodof up to 12 months.Enrollment: 10 of 10

6. Title: QmapatrilatCardiovascularTreatmentAssessment Versus EnalaprilzOCTAVE(phase III).Sponsor: Bristol-Myers SquibbDates of Participation: November2000 - March 2001

DS 2/08

Summary/Objective:To compare the reduction in systolic blood pressure at thecompletion of 8 weeks of titrated therapy.Enrollment: 4

7. Title: Efficacyand Safety Study of the Oral Direct ThrombinInhibitorof H 376/95Compared withDose-AdjustedWarfarin (Coumadin) in the Preventionof Stroke andSystemic Embolic Events in Patients withAtrial Fibrillation:Sportif V (phase III).Sponsor: AstraZenecaDates of Participation: November2000 — April2003Summary/Objective:To determine whether H 376/95 is non-inferior compared to dose-adjustedwarfarin aiming for an INR 2.0 -3.0 for the prevention of all strokes (fatal andnon-fatal) and systemic embolic events in patients with chronic non—valvular AF.Enrollment: 12

8. Title: A Randomized, Placebo-Controlled,Three TreatmentArm Study to Determinethe Safety and Efficacyof Argatroban Injection in Patients with Acute Ischemic Stroke:ARGIS-1 (phase II).Sponsor: TexasBiotechnology CorporationDates of Participation: April 2001 — September2002Summary/Objective:To determine the safety of Argatroban Injection in the treatment ofpatients with acute ischemic stroke.Enrollment: 4

9. Title: Compliance Assessment for Reminyl: CARE Trial (phase IV)Sponsor: Janssen Pharmaceutica, Inc.Dates of Participation: April2001 — March 7002Summary/Objective:Demonstrate eqivalence of b.i.d. dosing of Reminyl compared to qh.s. dosing of vitamin E in regards to compliance.Enrollment: 4

10. Title: Prospective, Open-Label Tolerabilityand Safety Monitoring Study ofNovantrone in a Selected Cohort of Multiple Sclerosis Patients: RENEW (phase IV)Sponsor: Immunex CorporationDates of Participation: May 2001 — April 2008Summary/Objective:Collect data relevant to the tolerabilityofNovantrone therapy inpatients withMS using dosing and monitoring specified in package insert.Enrollment: 12

11. Title: A Multicenter, Phase IV, Randomized, Open-Label Study to Compare theEfficacyof Two Therapies (Acetaminophenand Prednisone in the Management of Flu-Like Symptoms Associated withAVONEX® (Interferon beta-la) Treatment in PatientswithRelapsing Multiple SclerosisSponsor: Biogen, Inc.Dates of Participation: May 2001 — April2002Summary/Objective:To compare the efficacyof prednisone and acetaminophen in themanagementof flu-likesymptoms over 12 weeks of treatment withAVONEX®.

DS 2/08

Enrollment: 1

12. Title: A randomized, multicenter, parallel group, open-label study comparing thetolerabilityof Rebifinjection withand without the use of Rebijectm Mini in relapsingremitting MS patients.Sponsor: SeronoDates of Participation: November2001 ——— October 2002

,

Summary/Objective: To assess the effect of Rebijectm Mini on the safety andtolerabilityof Rebiftherapy in Relapsing MS patients.Enrollment: 16

13. Title: A 12 week, double-blind,placebo controlled, parallel group study to assess the

efficacyand safety of Ropinirole in patients suffering from Restless Legs Syndrome(RLS) (phase III)Sponsor: GlaxoSmithKlineDates of Participation: March 2002 — November2002

Summary/Objective:To compare the efficacy (1°) and safety, tolerabilityand beneficial

patient-reported outcomes (2°) of Ropinirole and placebo in the treatment of patients withRLS.Enrollment: 5

14. Title: Escitalopram effects on quality of lifeProtocol: SCT-MD-25Sponsor: Forest Laboratories, Inc.Dates of Participation: September2002 — November2002Summary/Objective: An 8 week, phase IV study to assess Escitalopram (Lexapro) on

the quality of life in the treatment of patients withmajor depression.Enrollment: 5 of 5

15. Title: Double-blind,placebo-controlled,12-week parallel group study to evaluate

safety and efficacyof oral Fampridine-SR in subjects withmoderate to severe spasticityresulting from chronic, incomplete spinal cord injury (phase III)Protocol: SCI-F302Sponsor: Acorda Therapeutics, Inc.Dates of Participation: October 2002 —— December3003Summary/Objective:To evaluate the clinical efficacy and safety of Fampridine-SR 25mg bid in the treatment of moderate to severe spasticity in subjects withchronic spinalcord injury who may or may not be treated with concurrent anti-spasticitymedications.Enrollment: 9

16. Title: Open-Label extension of double-blind, placebo-controlled,parallel group studyto evaluate safety, tolerabilityand activityof oral Fampridine-SR in subjects with

chronic, incomplete spinal cord injury.Protocol: SCI-F300 EXTSponsor: Acorda Therapeutics, Inc.Dates of Participation: September2003 —- September2004

DS 2/08

Summary/Objective:To evaluate the long term safety and tolerabilityof Fampridine-SRin subjects who participated in either SCI-F301 or SCI-F302. '

Enrollment: 16

17. Title: A Multicenter, Randomized, Placebo-controlled,Double-blind,Parallel-groupTrial to Evaluate Early Efficacyand Tolerabilityof Zolmitriptan (Zomig) Nasal Spray inthe Acute Treatmentof Adult Subjects withMigraine (phase III)Sponsor: AstraZenecaDates of Participation: November2002 —— July 2003Summary/Objective:To evaluate early efficacy (as assessed by the percentage of

responders) of Zolmitriptan 5 mg nasal spray dose in the acute treatment of adult patientswithmigraine.Enrollment: 1 (3 week enrollment for our site—3 screened)

18. Title: Double-blindRandomizedTrialof Cognitive Effects of LAMICTAL(lamotrigine) versus Topiramate in Epilepsy (phase III)Sponsor: GlaxoSmithKlineDates of Participation: March 2003 — February 2005Summary/Objective:To compare the cognitive effects of Topiramate and Lamictal as

adjunctive therapy in adult patients withpartial seizures.Enrollment: 5

19. Title: Randomized, Double-Blind, Double—Dummy, Placebo-Controlled,Multi-Center Trial Comparing the Effects of Orally AdministeredXyrem® (sodium oxybate)and Modafinil withPlacebo in the Treatmentof Daytime Sleepiness in Narcolepsy (phaseIII)Sponsor: Orphan MedicalDates of Participation: April2003 — August 2004Summary/Objective:Efficacymeasures are daytime sleepiness as measured byobjective response in the Maintenance of Wakefulness Test at the end of the double-blindtreatment period as compared to placebo.Enrollment: 5

20. Title: Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low—andHigh-Dose CAMPATH®and High-Dose Rebif® in Patients withEarly,ActiveRelapsing-Remitting Multiple SclerosisSponsor: IlexOncology/GenzymeDates of Participation: July 2003 — June 2010Summary/Objective:To reduce the time to sustained accumulationof disability(SAD)and reduce relapse rate.Enrollment:

DS 2/08

21. Title: Phase IV, Randomized, Open-Label Study Comparing Efficacyof DoseEscalation of AVONEXplus Acetaminophen or Ibuprofen Therapy versus

AcetaminophenAlone in the Management of Flu—Like Symptoms Associated withAVONEX Therapy in Patients with Relapsing Multiple Sclerosis.Sponsor: BiogenDates of Participation: May 2003 -— April2005Summary/Objective: To compare the incidence of flu—like symptoms using thefollowing side effect managementprotocols: acetaminophenalone, dose escalation ofAVONEX® in combinationwith acetaminophen,or dose escalation of AVONEX®with

ibuprofen.Enrollment: 4

22. Title: The EDSS Calculator for a PDA Using Palm OS or Windows CE OperatingSystem: A Reliabilityand Validity StudySponsor: TEVANeuroscienceDates of Participation: November2003 -- April2004Summary/Objective: Assess the extent to which the EDSS Calculator reflects the true

disabilitylevel of the subjects when compared to the pen and paper EDSS evaluation.Enrollment: 10 of 10

23. Title: A 12 Month, Open-Label, Flexible-Dosage(100 to 250mg/day) Study of theSafety and Efficacyof CEP—l0953 in the Treatmentof Patients with Excessive SleepinessAssociated withNarcolepsy, Obstructive Sleep Apnea/HypopneaSyndrome, or ChronicShift Work Sleep DisorderSponsor: CephalonDates of Participation: April2004 —- October 2005Summary/Objective:To determine whether treatment withCEP-10953 is more effectivethanplacebo treatment for patients withexcessive sleepiness associated with OSAHS bymeasuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) and byClinical Global Impression of Change.Enrollment: 2 (5 ready to enroll——-enrollment closed)

24. Title: A Multicenter, Randomized, Double-Blind,Placebo-Controlled,Phase 11 Studyof Efficacyand Safety of SGS742 in Subjects withMild to Moderate Alzheimer’sDiseaseSponsor: Saegis Pharmaceuticals, Inc.Dates of Participation: April2004 -— June 2005Summary/Objective:To determine the effect of SCS742 on memory and cognition inolder individuals withdiminished memory function who meet prospective criteria formild to moderate Alzheimer’s disease using the Alzheimer’s disease Assessment Scale

_

(ADAS-Cog)Enrollment: 4

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25. Title: A Randomized, Doubled-Blind, Placebo-ControlledStudy to Evaluate the

Safety, Tolerabilityand Efficacyof NBI-5788 in Patients with Relapsing MultipleSclerosis (phase II).Sponsor: NeurocrineDates of Participation: June 2004 — April2005 ’

.

Summary/Objective:To evaluate the safety and tolerabilityof NBI-5788 administeredsubcutaneouslyfor nine months and to compare the effect ofNBI-5788 and placebotherapy on a summary change score for total Gd-enhancing cranial MRI lesions after ninemonths of treatment.Enrollment: 1 (7 screened)

26. Title: A 12-week, Double-Blind,Placebo Controlled, TwiceDailyDosing Study to

Assess the Efficacyand Safety of Ropinirole in Patients Suffering from Restless

Legs Syndrome (RLS) Requiring Extended TreatmentCoverage (phase Illb)013

Sponsor: GlaxoSmithKlineDates of Participation: October 2004 — August 2005Summary/Objective:To compare the efficacy and safety of Ropinirole and placebousing a twice daily dosing regimen in subjects with RLS requiring extended treatment

coverage. To assess the safety, tolerabilityand beneficialsubject-reported outcomes of

Ropinirole and placebo using twice daily closing in the treatment of subjects with RLS

requiring extended treatment coverage.Enrollment: 6

27.Title: A Prospective, Multi—Center, Randomized, Open-Label Study withBlindedRaters to Evaluate the Effects of Immediate versus Delayed Switch to Stalevo® on MotorFunction and Quality of Life in Patients withParkinson’sDisease with End—of—DoseWearing Off (phase IV)Sponsor: NovartisDates of Participation: February 2005 — August 2007Summary/Objective: To assess changes in motor function and quality of life, in patientswithParkinson’sdisease withEODWO, by comparing the change from baseline to Week4 between immediate-switchand delayed-switch treatment arms.

Enrollment: 5

28.Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assessthe Efficacyand Safety of Ropinirole XR (Extended Release) in Patients withRestlessLegs SyndromeSponsor: GSKDates of Participation: April2005 -— October 2005Summary/Objective:To compare the efficacy and safety of ropinirole XR and placeboin adult patients with RLS requiring early evening and nighttime coverage of RLS

symptomsA

Enrollment: 3 (enrollment closed 13 weeks early)

29.Title: A Short-Term(8-Week)Open-Label study, Followed by a Long-TermEvaluation, to Assess Patient-Reported Outcomes WithArmodafinilTreatment(150 to

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250 mg/day) for Excessive Sleepiness in Adults WithNarcolepsy or Obstructive SleepApnea/HypopneaSyndromeSponsor: CephalonDates of Participation: September2005 — October 2006Summary/Objective:To assess patient—reported outcomes witharmodafinil treatment

interms of improvement in excessive sleepiness, satisfactionwithtreatment, impact on

abilityto engage in life activities (i.e., dailyor work and familyand/or social activities),and effects on fatigue.Enrollment: 11

30. Title: A Multicenter, Double-Blind,Randomized Conversion to MonotherapyComparison of Two Doses of Lamotrigine for the Treatmentof Partial Seizures

Sponsor: GSKDates of Participation: April2006 — August 2007Summary/Objective:To demonstrate the efficacyof LTG at 250mg/d and 300mg/dcompared to pooled historic pseudoplacebo data. To evaluate the safety and tolerabilityof LTG extended release as monotherapy.

3

Enrollment: 3 (enrollment requested 2)

31. Title: A Randomized, Double-Blind,Placebo-ControlledStudy to Assess the

Efficacyand Safety of XPl 3512 in Patients withRestless Leg Syndrome.Sponsor: XenoportDates of Participation: May 2006 — February 2008Summary/Objective:To compare the efficacyof XP135 12 l200mg taken once dailyversus placebo for the treatment of RLS.Enrollment: 6

32. Title: A Phase IV randomized, double-blind,active and placebo~controlled,6-weektrial to investigate the efficacyand safety of a starting (and fixed) dose 0.25 mgpramipexole (Mirapex®) in patients with idiopathicRestless Legs SyndromeSponsor: Boehringer IngelheimDates of Participation: September2006 —— October 2007Summary/Objective:To investigate the efficacyand safety of 0.25 mg dailypramipexole compared to a starting dose of 0.125 mg.Enrollment: 4

33. Title: Open-label,multicenter, single treatment effectiveness and safety study ofonce dailyAzilect®as mono- or adjuncttherapy in patients with idiopathicParkinson’sdisease (PD)Sponsor: TEVADates of Participation: November2006 — August 2007Summary/Objective:To characterizethe time to onset of symptomatic effect of Azilectas initial monotherapyand as adjuncttherapy and to characterizethe effectiveness ofAzilectbeyond the registration program by incorporating physicianand patient-ratedsatisfactionand ease-of-use scalesEnrollment: 6

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34. Title: A 24-monthdouble-blind, randomized,milticenter, placebo-controlled,parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod(FTY720)administered orally once dailyversus placebo inpatients with relapsing-remitting multiple sclerosisSponsor: Novartis

.

Dates of Participation: November2006 - August 2011Summary/Objective:To compare fingolimod 1.25 mg and 0.5 mg withplacebo and to

demonstrate thatat least 1.25 mg fmgolimod is superior to placebo in terms of annualizedrelapse rate for patients withRRMS treated for up to 24 months.Enrollment: 11 A

35. Title: Extension to CFTY720D2309Sponsor: NovartisDates of Participation: February 2010 - presentSummary/Objective: to provide long-term safety, tolerabilityand efficacy data ofFTY720in patients withMS. All patients thathave completed the 24-monthcore study

i

may enter the extension and wil be offered FTY720treatment until the drug becomesavailableof the marketor until development is terminated.Enrollment: 6

36. Title: ELN1 15727- 301: A phase III, milticenter, randomized, double-blind,placebo-controlled,parallel group, efficacyand safety trial of bapineuzumab (AAB-001,ELN115727) in patients withmild to moderate Alzheimer’s disease who are

Apolipoprotein E e4 carriers. 3

Sponsor: JanssenDates of Participation: February 2008 - presentSummary/Objective:To demonstratean advantage of the efficacyof multiple doses ofintravenously (IV) administered bapineuzumab in patients withmild to moderate ADover placebo.Enrollment: 3

37. Title: ELN1 15727- 302: A phase III, milticenter, randomized, double-blind,placebo—controlled,parallel group, efficacyand safety trial of bapineuzumab (AAB-001,ELN1 15727) in patients withmild to moderate Alzheimer’s disease who are

Apolipoprotein E e4 carriers. 0

Sponsor: JanssenDates of Participation: February 2008 - presentSummary/Objective:To demonstrate an advantage of the efficacyof multiple doses ofintravenously (IV) administered bapineuzumab in patients withmild to moderate ADover placebo.Enrollment: 6

38_. Title: 351: A phase 3, extension, multicenter, double-blind, long term safety andtolerabilitytreatment trial of bapineuzumab in subjects withAlzheimer’s disease whoparticipated in study ELN1 15727-301 or 302Sponsor: Janssen

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Dates of Participation: August 2009 — November2012Summary/Objective: to evaluate the long-term safety and efficacyof IV bapineuzumabin patients withADEnrollment: 6

39. Title: A phase 2, randomized,double-blind,placebo—controlled,parallel group,,

multi-center, biomarker,safety and pharmacokineticstudy of bapineuzumab (AAB-001)administered subcutaneouslyat monthly intervals in subjects withmild to moderateAlzheimer’s diseaseSponsor: Janssen Alzheimer ImunotherapyDates of Participation: November2010 - April 2013Summary/Objective: to assess the effect of bapineuzumab administered SC at monthlyintervals, at doses of 2,7, and 20 mg, compared to placebo on cerebral amyloid burden in

subjects withmild to moderate ADEnrollment: 2

40. Title: CARE-MS ll CAMMS324: A phase 3 randomized, rater-and dose-blindedstudy comparing two annual cycles of intravenous low- and high-dose Alemtuzumab to

three-timesweekly subcutaneous interferon Beta-la (Rebif) in patients withRRMS whohave relapsed on therapySponsor: Genzyme CorpDates of Participation: March 2008 — December2011

Summary/Objective: to compare the safety and efficacyof 2 annual cycles of 12mg/dayintravenous alemtuzumab to 3-times weekly SC interferon beta-la in patients withactive

1‘elapsing—remitting MS0

Enrollment: 3

41. Title: CAMMSO3409: An extension protocol for MS patients who participated in

Genzyme-sponsored studies of AlemtuzumabSponsor: GenzymeDates of Participation: June 2011 - presentEnrollment: 2

42. Title: A phase 3, multicenter, randomized, placebo—controlled,double—blind twelve-month safety and efficacy study evaluating Dimebon in patients withmild to moderateAlzheimer’s disease on DonepezilSponsor: MedivationDates of Participation: March 2009 — March 2012Summary/Objective: to assess the efficacyof dimebon as compared to placebo on

ADAS-cog,ADL, CIBIC-plus and the safety and tolerabilityof 5mg and 20mg orallyTID over 52 weeks in patients withmild to moderate AD who are on a stable dose ofdonepezilEnrollment: 3

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43. Title: A randomized, double-blind,double-dummy,parallel-group study to evaluatethe efficacyand safety of Ocrelizumab in comparison to Interferon beta la (Rebif) in

patients with relapsing multiple sclerosisSponsor: Roche, GenentechDates of Participation: August 2011—- presentSummary/Objective: to assess whether the efficacyof ocrelizumab 600 mg (given as

dual infusions of 300 mg ocrelizumab 14 days apart) intravenouslyevery 24 weeks is

superior to Rebifas measured by the annualizedprotoco1—defmed relapse rate by two

years in patients with relapsing MS.-Enrollment: 3

44. Title: A randomized, double-blind,placebo-controlled,parallel-group, 18-monthsafety and efficacystudy of Leuco-methylthioniniumbis in subjects withmildAlzheimer’s diseaseSponsor: TauRxDates of Participation: September2013 —- presentEnrollment: 5

45. Title: A Phase 3, 12-week, double-Blind,Placebo-controlled,Randomized,Multicenter Study to Evaluate the Efficacyof Oral Istradefylline20 and 40 mg/day as

Treatmentfor Subjects withModerate to Severe Parkinson’sDiseaseSponsor: KyowaDates of Participation: March 2014 -- presentEnrollment: 6

46. Title: Efficacyand Safety of ADS-5102 (AmantadineHCL) Extended ReleaseCapsules for the Treatmentof Levodopa Induced Dyskinesia in Parkinson’sDiseasePatients (Ease LID Study)Sponsor: AdamasPharmaceuticals, Inc.Dates of Participation: October 2014 -- presentEnrollment: 3

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