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

Information source: IMPAX Laboratories, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease

Intervention: IPX066 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: IMPAX Laboratories, Inc.

Official(s) and/or principal investigator(s):
IPX066-B09-03 Impax Study Director, Study Director, Affiliation: Impax Pharmaceuticals, a division of Impax Laboratories

Summary

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Unified Parkinson's Disease Rating Scale (UPDRS), parts I-IV

Secondary outcome:

Parkinson's Disease Questionnaire-39 (PDQ-39)

Patient Global Impression (PGI)

Detailed description: IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066:

- IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066

in Subjects with Parkinson's Disease)

- IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to

Standard Carbidopa - Levodopa)

- IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced

Parkinson's Disease) All participants will be given IPX066 for 9 months.

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Each subject must meet the following inclusion criteria in order to be enrolled in

the study: 1. Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02. 2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy. Exclusion Criteria:

- Each subject must be free of the following exclusion criteria in order to be enrolled

in the study: 1. Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment. 2. Anticipates functional neurosurgical treatment for PD (e. g., ablation or deep brain stimulation) during study participation. 3. Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline). 4. In the opinion of the Investigator, should not participate in the study.

Locations and Contacts

Quebec Memory & Motor Skills Disorders Clinic, Quebec G1R 3X5, Canada

East Tallinn Central Hospital, Tallinn 10138, Estonia

West Tallinn Central Hospital,, Tallinn 10617, Estonia

Neurologiepraxis, Berlin 12163, Germany

Neurozentrm - Praxis fur Neurologie und Psychiatrie, Berlin 10437, Germany

Gailezers hospital, Riga, Latvia

P.Stradina university hospital, Riga 1002, Latvia

Kaunas Medical University Hospital, Kaunas LT-50009, Lithuania

Siauliai Regional Hospital, Siauliai LT-76231, Lithuania

National Centre of Osteoporosis, Vilnius LT-01102, Lithuania

Vilnius University Emergency Hospital, Vilnius LT-04130, Lithuania

Vilnius University Hospital Santariskiu klinikos, Vilnius LT-08661, Lithuania

Neuro-Care NZOZ, Katowice 40-546, Poland

Neomed Research, Brasov 500283, Romania

Psychiatry and Neurology Hospital Brasov, Neurology Department, Brasov 500123, Romania

Colentina Clinical Hospital Bucharest, II Neurology Department, Bucharest 020125, Romania

CFR Clinical Hospital Constanta, Neurology Department, Constanta 900123, Romania

Clinical Rehabilitation Hospital Iasi, Neurology Department, Lasi 700661, Romania

County Clinical Emergency Hospital Targu Mures, I Neurology Department, Targu Mures 540136, Romania

County Clinical Emergency Hospital Targu Mures, II Neurology Department, Targu Mures 540136, Romania

County Clinical Emergency Hospital Timisoara, Neurology Department, Timisoara 300736, Romania

Clinica Ruber SA, Madrid 28006, Spain

Department of neurology and neurosurgery of Dnipropetrovsk State Medical Academy based on Dnipropetrovsk regional hospital named after Mechnikov, Dnipropetrovsk 49005, Ukraine

Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University, Donetsk 83099, Ukraine

Department of Psychiatry and Medical Psychology of Donetsk National Medical University, Donetsk 83037, Ukraine

1st neurology department of Central Clinical Hospital of Ukrzaliznytsya, Kharkiv 61058, Ukraine

Department of Vascular Pathology of brain of Institute of neurology, psychiatry and narcology of AMS of Ukraine, Kharkiv 61068, Ukraine

Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Kharkiv 61068, Ukraine

Neurology department of Lviv regional clinical hospital, Lviv 79010, Ukraine

Odessa Regional Clinical Hospital, Dept. of Neurosurgery, Odesa 65025, Ukraine

Neurology department of Medical Dental Academy based on Poltava regional hospital, Poltava, 36000, Ukraine

Vinnytsia Regional Psycho-Neurological Hospital, Vinnytsia 21005, Ukraine

Zaporizhzhya State Medical University based at Zaporizhzhya State Clinical Hospital #6, Zaporizhzhya 69035, Ukraine

Zaporozhye Regional Clinical Hospital, Zaporozhye 69600, Ukraine

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States

HOPE Research Institute, Phoenix, Arizona 85050, United States

Mohammed Ali Parkinson's Center, Phoenix, Arizona 85013, United States

Clinical Trials Inc., Little Rock, Arkansas 72205, United States

Hospital General de Cataluña, Sant Cugat Del Valles, Barcelona 08195, Spain

Coastal Neurological Medical Group, La Jolla, California 92037, United States

Coordinated Clinical Research, La Jolla, California 92037, United States

The Parkinson's Institute, Sunnyvale, California 94085, United States

Collaborative NeuroScience Network, Inc., Torrance, California 90502, United States

Bradenton Research Center, Inc., Bradenton, Florida 34205, United States

Sunrise Clinical Research, Hollywood, Florida 33021, United States

Renstar Medical Research, Ocala, Florida 34471, United States

Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida, Port Charlotte, Florida 33980, United States

Suncoast Neuroscience Associates, Inc., Saint Petersburg, Florida 33713, United States

University of South Florida, Parkinson's Disease and Movement Disorders Center, Tampa, Florida 33603, United States

Medical College of Georgia, Movements Disorders Clinic, Augusta, Georgia 30912, United States

Movement Disorder Center at Idaho Elks Rehabilitation Hospital, Boise, Idaho 83702, United States

Northwestern University, Feinberg School of Medicine, Dept. of Neurology, Chicago, Illinois 60611, United States

Rush University Medical Center, Chicago, Illinois 60612, United States

Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

PALLMED Sp. z o.o., Bydgoszcz, Kujawsko-pomorskie 85-796, Poland

Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, SPZOZ w Lublinie, Lublin, Lubelskie 20-718, Poland

Krakowska Akademia Neurologii Sp. z o. o., Kraków, Malopolskie 31-530, Poland

Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A., Warszawa, Mazowieckie 02-777, Poland

Quest Research Institute, Bingham Farms, Michigan 48025, United States

Struthers Parkinson's Center, Golden Valley, Minnesota 55427, United States

UMDNJ Robert Wood Johnson Medical Center, Department of Neurology, New Brunswick, New Jersey 08901, United States

Albany Medical College, Parkinson's Disease and Movement Disorders Center, Albany, New York 12208, United States

David L. Kreitzman, MD, P.C., Commack, New York 11725, United States

Columbia University Neurological Institute, New York, New York 10032, United States

Institute for Human Performance, Syracuse, New York 13210, United States

Praxis für Neurologie und Psychiatrie, Westerstede, Niedersachsen 26655, Germany

Duke University Medical Center Movement Disorders Center, Durham, North Carolina 27707, United States

University Neurology, Inc., Cincinatti, Ohio 45219, United States

University of Toledo, Toledo, Ohio 43614, United States

The Movement Disorder Clinic of Oklahoma, Tulsa, Oklahoma 74136, United States

London Health Sciences Centre, University Hospital, London, Ontario N6A 5A5, Canada

Ottawa Hospital Civic Site, Ottawa, Ontario K1Y 4E9, Canada

Parkinson's & Neurodegenerative Disorder Clinic, Ottawa, Ontario K1G 4G3, Canada

Medical University of South Carolina, Charleston, South Carolina 29401, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75390-9184, United States

Baylor College of Medicine, Houston, Texas 77030, United States

South Puget Sound Neurology, Tacoma, Washington 98405, United States

Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska, Mosina, Wielkopoloskie 62-050, Poland

Wisconsin Institute for Neurologic and Sleep Disorders, Milwaukee, Wisconsin 53233, United States

Euromedis Sp. z o.o., Szczecin, Zachodniopomorskie 70-215, Poland

Additional Information

Starting date: March 2010
Last updated: September 27, 2013

Page last updated: August 23, 2015

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