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

Novartis

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Entacapone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00237263

CCOM998A1204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 285 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)