A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

October 31, 2010

Study Completion Date

November 30, 2010

Conditions
Parkinson's Disease
Interventions
DRUG

Placebo

Placebo

DRUG

IPX066 95 mg LD

IPX066 capsule containing 95 mg LD/23.75 mg CD

DRUG

IPX066 145 mg LD

IPX066 capsule containing 145 mg LD/36.25 mg CD

DRUG

IPX066 195 mg LD

IPX066 capsule containing 195 mg LD/48.75 mg CD

DRUG

IPX066 245 mg LD

IPX066 capsule containing 245 mg LD/61.25 mg CD

Trial Locations (60)

1002

P.Stradina university hospital, Riga

10029

Mount Sinai School of Medicine, New York

10032

Columbia University, New York

10138

East Tallinn Central Hospital, Tallinn

10617

West Tallin Central Hopsital, Tallinn

13210

State University of New York Upstate Medical University, Dept. of Neurology, Syracuse

21018

Neurology department of Vinnitsa Medical University, Vinnitsa

23021

Sunrise Clinical Research, Inc., Hollywood

27705

Duke University Medical Center Movement Disorders Center, Durham

33612

University of South Florida, Tampa

33713

Suncoast Neuroscience Associates, Inc., St. Petersburg

33952

Charlotte Neurological Services, Port Charlotte

34205

Bradenton Research Center, Inc., Bradenton

34471

Renstar Medical Research, Ocala

35233

University of Alabama at Birmingham, Dept. of Neurology, Birmingham

36000

Neurology department of Medical Dental Academy based on Poltava regional hospital, Poltava

43614

University of Toledo, Toledo

48025

Quest Research Institute, Bingham Farms

49005

Neurology department of Regional hospital named after Mechnikov, Dnipro

53233

Wisconsin Institute for Neurologic and Sleep Disorders, Milwaukee

55427

Struthers Parkinson's Center, Golden Valley

60612

Rush University Medical Center, Dept. of Neurological Sciences, Chicago

69035

Neurology department, Zaporozhye State Medical University, Zaporizhzhya

77030

Baylor College of Medicine, Parkinson's Disease Center, Houston

79010

Neurology department of Lviv regional clinical hospital, Lviv

83037

Department of Psychiatry and Medical Psychology of Donetsk National Medical University, Donetsk

83099

Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University, Donetsk

83702

Idaho Elks Rehabilitation Hospital, Boise

85050

HOPE Research Institute, LLC, Phoenix

92037

Coastal Neurological Medical Group, La Jolla

Coordinated Clinical Research, La Jolla

92845

Collaborative NeuroScience Network, Inc., Garden Grove

94085

The Parkinson's Institute, Sunnyvale

300736

County Clinical Emergency Hospital Timisoara, Timișoara

400012

County Emergency Clinical Hospital Cluj-Napoca, I Neurology Clinic, Cluj-Napoca

500123

Psychiatry and Neurology Hospital, Neurology Department, Brasov

540136

County Clinical Emergency Hospital, Targu Mures, II Neurology Department,, Târgu Mureş

900123

CFR Clinical Hospital Constanta, Constanța

06510

Yale Neurology Clinics, Temple Medical Center, New Haven

66160-7314

Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center, Kansas City

02118

Boston University School of Medicine, Boston

08901

UMDNJ Robert Wood Johnson Medical Center, Department of Neurology, New Brunswick

T5G 0B7

Movement Disorders Clinic, Glenrose Rehabilitation Hospital, Edmonton

R3J2H7

Saint Boniface Clinic, Winnipeg

N6A 5A5

London Health Science Center, London

K1G 4G3

Parkinson's and Neurodegenerative Disorders Clinic, Ottawa

K1Y 4E9

Ottawa Hospital Civic Site, Ottawa

M5T 2S8

Toronto Western Hospital, Toronto

G1R 3X5

Memory and Motor Skills Clinic, Québec

J1H 5N4

University of Sherbrooke, Sherbrooke

Unknown

Gailezers hospital, Riga

Clinical Rehabilitation Hospital Iasi, Neurology Department, Iași

LT-50009

Kaunas Medical University Hospital, Kaunas

LT- 76231

Siauliai Regional Hospital, Šiauliai

LT-04130

Vilnius University Emergency Hospital, Vilnius

LT-08420

Vilnius University Centre of Gerontology and Rehabilitation, Vilnius

LT-08661

Vilnius University Hospital Santariskiu klinikos, Vilnius

020125

Colentina Clinical Hospital Bucharest, II Neurology Department, Bucharest

Kharkiv

1st neurology department of Central Clinical Hospital of Ukrzaliznytsya, Kharkiv

04114

Institute of Gerontology Parkinson's Disease Center, Kiev

Sponsors
All Listed Sponsors
lead

Impax Laboratories, LLC

INDUSTRY

NCT00880620 - A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease | Biotech Hunter | Biotech Hunter