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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096186
• Other study ID #: IPX066-B09-03
• Status: Completed
• Phase: Phase 3
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2017
• Source: Impax Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 617
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• IPX066 95 mg
23.75 - 95 mg CD-LD capsules
• IPX066 145 mg
36.25 - 145 mg CD-LD capsules
• IPX066 195 mg
48.75 - 195 mg CD-LD capsules
• IPX066 245 mg
61.25 - 245 mg CD-LD capsules

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Impax Laboratories, LLC

Countries where clinical trial is conducted

United States,  Canada,  Estonia,  Germany,  Latvia,  Lithuania,  Poland,  Romania,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III	Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at End of Study.; Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.; Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25	9 months
Secondary	Total UPDRS Parts I-IV	Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy [In the past week]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient.; Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.; Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25	9 months
Secondary	Patient Global Impression (PGI)	Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale.; Patient Global Impression 0-7 - higher value indicates increased improvement from study start	9 months