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
• Status: Completed
• Phase: Phase 2
• Start date: February 2003
• Est. completion date: July 2007

Study information

• Verified date: January 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

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