Clinical trial NCT01096186: An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
Official title: An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: motor Symptoms
efficacy
IPX066
Parkinson's Disease
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2010-03-31
Enrollment: 617
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III
timeFrame: 9 months
Secondary outcomes:
measure: Total UPDRS Parts I-IV
timeFrame: 9 months
measure: Patient Global Impression (PGI)
timeFrame: 9 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mohammed Ali Parkinson's Center
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Little Rock
country: United States
facility: Clinical Trials Inc.
state: Arkansas
city: La Jolla
country: United States
facility: Coastal Neurological Medical Group
state: California
city: La Jolla
country: United States
facility: Coordinated Clinical Research
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute
state: California
city: Torrance
country: United States
facility: Collaborative NeuroScience Network, Inc.
state: California
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc.
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Parkinson's Disease and Movement Disorders Center
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia, Movements Disorders Clinic
state: Georgia
city: Boise
country: United States
facility: Movement Disorder Center at Idaho Elks Rehabilitation Hospital
state: Idaho
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine, Dept. of Neurology
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Golden Valley
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: New Brunswick
country: United States
facility: UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College, Parkinson's Disease and Movement Disorders Center
state: New York
city: Commack
country: United States
facility: David L. Kreitzman, MD, P.C.
state: New York
city: New York
country: United States
facility: Columbia University Neurological Institute
state: New York
city: Syracuse
country: United States
facility: Institute for Human Performance
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Movement Disorders Center
state: North Carolina
city: Cincinnati
country: United States
facility: University Neurology, Inc.
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Tulsa
country: United States
facility: The Movement Disorder Clinic of Oklahoma
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Tacoma
country: United States
facility: South Puget Sound Neurology
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Institute for Neurologic and Sleep Disorders
state: Wisconsin
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Parkinson's & Neurodegenerative Disorder Clinic
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Civic Site
state: Ontario
city: Quebec
country: Canada
facility: Quebec Memory & Motor Skills Disorders Clinic
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital,
city: Westerstede
country: Germany
facility: Praxis für Neurologie und Psychiatrie
state: Niedersachsen
city: Berlin
country: Germany
facility: Neurozentrm - Praxis fur Neurologie und Psychiatrie
city: Berlin
country: Germany
facility: Neurologiepraxis
city: Riga
country: Latvia
facility: P.Stradina university hospital
city: Riga
country: Latvia
facility: Gailezers hospital
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Hospital
city: Siauliai
country: Lithuania
facility: Siauliai Regional Hospital
city: Vilnius
country: Lithuania
facility: National Centre of Osteoporosis
city: Vilnius
country: Lithuania
facility: Vilnius University Emergency Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu klinikos
city: Bydgoszcz
country: Poland
facility: PALLMED Sp. z o.o.
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, SPZOZ w Lublinie
state: Lubelskie
city: Kraków
country: Poland
facility: Krakowska Akademia Neurologii Sp. z o. o.
state: Malopolskie
city: Warszawa
country: Poland
facility: Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
state: Mazowieckie
city: Mosina
country: Poland
facility: Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska
state: Wielkopoloskie
city: Szczecin
country: Poland
facility: Euromedis Sp. z o.o.
state: Zachodniopomorskie
city: Katowice
country: Poland
facility: Neuro-Care NZOZ
city: Brasov
country: Romania
facility: Psychiatry and Neurology Hospital Brasov, Neurology Department
city: Brasov
country: Romania
facility: Neomed Research
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital Bucharest, II Neurology Department
city: Constanta
country: Romania
facility: CFR Clinical Hospital Constanta, Neurology Department
city: Lasi
country: Romania
facility: Clinical Rehabilitation Hospital Iasi, Neurology Department
city: Targu Mures
country: Romania
facility: County Clinical Emergency Hospital Targu Mures, I Neurology Department
city: Targu Mures
country: Romania
facility: County Clinical Emergency Hospital Targu Mures, II Neurology Department
city: Timisoara
country: Romania
facility: County Clinical Emergency Hospital Timisoara, Neurology Department
city: Sant Cugat Del Valles
country: Spain
facility: Hospital General de Cataluña
state: Barcelona
city: Madrid
country: Spain
facility: Clinica Ruber SA
city: Dnipropetrovsk
country: Ukraine
facility: Department of neurology and neurosurgery of Dnipropetrovsk State Medical Academy based on Dnipropetrovsk regional hospital named after Mechnikov
city: Donetsk
country: Ukraine
facility: Department of Psychiatry and Medical Psychology of Donetsk National Medical University
city: Donetsk
country: Ukraine
facility: Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University
city: Kharkiv
country: Ukraine
facility: 1st neurology department of Central Clinical Hospital of Ukrzaliznytsya
city: Kharkiv
country: Ukraine
facility: Department of Vascular Pathology of brain of Institute of neurology, psychiatry and narcology of AMS of Ukraine
city: Kharkiv
country: Ukraine
facility: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine
city: Lviv
country: Ukraine
facility: Neurology department of Lviv regional clinical hospital
city: Odesa
country: Ukraine
facility: Odessa Regional Clinical Hospital, Dept. of Neurosurgery
city: Poltava,
country: Ukraine
facility: Neurology department of Medical Dental Academy based on Poltava regional hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Psycho-Neurological Hospital
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya State Medical University based at Zaporizhzhya State Clinical Hospital #6
city: Zaporozhye
country: Ukraine
facility: Zaporozhye Regional Clinical Hospital
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Study Director
role: STUDY_DIRECTOR
References: