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
Phase 2
Completed
- Conditions
- Parkinson's Disease
- Registration Number
- NCT00237263
- Lead Sponsor
- Novartis
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 285
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence of adverse events during the long term treatment (maximum 3 years) ECG at every 16 weeks Blood pressure at every 12 weeks Laboratory test at every 16 weeks
- Secondary Outcome Measures
Name Time Method UPDRS score at every 16 weeks On time based on patient diary (up to 104 weeks)
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States