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NCT00237263 Clinical Trial

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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00237263
Other study ID # CCOM998A1204
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2003
Est. completion date July 2007

Study information
Verified date January 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 285
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Entacapone

Locations
Country Name City State
United States Novartis Pharmaceuticals East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events during the long term treatment (maximum 3 years)
Primary Blood pressure at every 12 weeks
Primary Laboratory test at every 16 weeks
Primary ECG at every 16 weeks
Secondary On time based on patient diary (up to 104 weeks)
Secondary UPDRS score at every 16 weeks
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