An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-Dose Wearing-Off. This Study is Not Recruiting in the United States - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00237263

Purpose

The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.

This study is not recruiting patients in the United States.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Entacapone	Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Entacapone OR 611

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Extension Study to Phase IIb Dose-Finding Study of Entacapone in Patients With Parkinson's Disease With End-of-Dose Wearing-Off

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of adverse events during the long term treatment (maximum 3 years)
Blood pressure at every 12 weeks
Laboratory test at every 16 weeks
ECG at every 16 weeks

Secondary Outcome Measures:

On time based on patient diary (up to 104 weeks)
UPDRS score at every 16 weeks

Estimated Enrollment:	300
Study Start Date:	February 2003
Study Completion Date:	July 2007

Detailed Description:

The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Attended the Phase IIb study
Able to fill out the patient diary

Exclusion Criteria:

Serious heart, pulmonary, renal, hepatic or gastrointestinal disease
Dementia symptoms
Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237263

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CCOM998A1204
Study First Received:	October 7, 2005
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00237263
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Parkinson's disease, end-of -dose wearing-off, entacapone

Study placed in the following topic categories:

Signs and Symptoms
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Entacapone

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Nervous System Diseases

Antiparkinson Agents
Enzyme Inhibitors
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009