An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

617

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
Parkinson's Disease
Interventions
DRUG

IPX066 95 mg

23.75 - 95 mg CD-LD capsules

DRUG

IPX066 145 mg

36.25 - 145 mg CD-LD capsules

DRUG

IPX066 195 mg

48.75 - 195 mg CD-LD capsules

DRUG

IPX066 245 mg

61.25 - 245 mg CD-LD capsules

Trial Locations (81)

1002

P.Stradina university hospital, Riga

10032

Columbia University Neurological Institute, New York

10138

East Tallinn Central Hospital, Tallinn

10437

Neurozentrm - Praxis fur Neurologie und Psychiatrie, Berlin

10617

West Tallinn Central Hospital,, Tallinn

11725

David L. Kreitzman, MD, P.C., Commack

12163

Neurologiepraxis, Berlin

12208

Albany Medical College, Parkinson's Disease and Movement Disorders Center, Albany

13210

Institute for Human Performance, Syracuse

21005

Vinnytsia Regional Psycho-Neurological Hospital, Vinnytsia

26655

Praxis für Neurologie und Psychiatrie, Westerstede

27707

Duke University Medical Center Movement Disorders Center, Durham

28006

Clinica Ruber SA, Madrid

29401

Medical University of South Carolina, Charleston

30912

Medical College of Georgia, Movements Disorders Clinic, Augusta

33021

Sunrise Clinical Research, Hollywood

33603

University of South Florida, Parkinson's Disease and Movement Disorders Center, Tampa

33713

Suncoast Neuroscience Associates, Inc., St. Petersburg

33980

Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida, Port Charlotte

34205

Bradenton Research Center, Inc., Bradenton

34471

Renstar Medical Research, Ocala

35233

University of Alabama at Birmingham, Birmingham

36000

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

43614

University of Toledo, Toledo

45219

University Neurology, Inc., Cincinnati

48025

Quest Research Institute, Bingham Farms

49005

Department of neurology and neurosurgery of Dnipropetrovsk State Medical Academy based on Dnipropetrovsk regional hospital named after Mechnikov, Dnipropetrovsk

50309

Iowa Methodist Medical Center, Des Moines

53233

Wisconsin Institute for Neurologic and Sleep Disorders, Milwaukee

55427

Struthers Parkinson's Center, Golden Valley

60611

Northwestern University, Feinberg School of Medicine, Dept. of Neurology, Chicago

60612

Rush University Medical Center, Chicago

61058

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

61068

Department of Vascular Pathology of brain of Institute of neurology, psychiatry and narcology of AMS of Ukraine, Kharkiv

Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Kharkiv

65025

Odessa Regional Clinical Hospital, Dept. of Neurosurgery, Odesa

66160

University of Kansas Medical Center, Kansas City

69035

Zaporizhzhya State Medical University based at Zaporizhzhya State Clinical Hospital #6, Zaporizhzhya

69600

Zaporozhye Regional Clinical Hospital, Zaporizhzhya

72205

Clinical Trials Inc., Little Rock

74136

The Movement Disorder Clinic of Oklahoma, Tulsa

77030

Baylor College of Medicine, 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

Movement Disorder Center at Idaho Elks Rehabilitation Hospital, Boise

85013

Mohammed Ali Parkinson's Center, Phoenix

85050

HOPE Research Institute, Phoenix

90502

Collaborative NeuroScience Network, Inc., Torrance

92037

Coastal Neurological Medical Group, La Jolla

Coordinated Clinical Research, La Jolla

94085

The Parkinson's Institute, Sunnyvale

98405

South Puget Sound Neurology, Tacoma

300736

County Clinical Emergency Hospital Timisoara, Neurology Department, Timișoara

500123

Psychiatry and Neurology Hospital Brasov, Neurology Department, Brasov

500283

Neomed Research, Brasov

540136

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

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

700661

Clinical Rehabilitation Hospital Iasi, Neurology Department, Lasi

900123

CFR Clinical Hospital Constanta, Neurology Department, Constanța

08901

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

75390-9184

University of Texas Southwestern Medical Center, Dallas

N6A 5A5

London Health Sciences Centre, University Hospital, London

K1G 4G3

Parkinson's & Neurodegenerative Disorder Clinic, Ottawa

K1Y 4E9

Ottawa Hospital Civic Site, Ottawa

G1R 3X5

Quebec Memory & Motor Skills Disorders Clinic, Québec

Unknown

Gailezers hospital, Riga

LT-50009

Kaunas Medical University Hospital, Kaunas

LT-76231

Siauliai Regional Hospital, Šiauliai

LT-01102

National Centre of Osteoporosis, Vilnius

LT-04130

Vilnius University Emergency Hospital, Vilnius

LT-08661

Vilnius University Hospital Santariskiu klinikos, Vilnius

85-796

PALLMED Sp. z o.o., Bydgoszcz

31-530

Krakowska Akademia Neurologii Sp. z o. o., Krakow

20-718

Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, SPZOZ w Lublinie, Lublin

02-777

Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A., Warsaw

70-215

Euromedis Sp. z o.o., Szczecin

62-050

Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska, Mosina

40-546

Neuro-Care NZOZ, Katowice

020125

Colentina Clinical Hospital Bucharest, II Neurology Department, Bucharest

08195

Hospital General de Cataluña, Sant Cugat del Vallès

Sponsors
All Listed Sponsors
lead

Impax Laboratories, LLC

INDUSTRY

NCT01096186 - An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease | Biotech Hunter | Biotech Hunter