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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00237263
• Collaborator: (none)
• Enrollment: 285
• Location: 1
• Duration (Months): 52.9
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Entacapone	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 285 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events during the long term treatment (maximum 3 years) []

2. Blood pressure at every 12 weeks []

3. Laboratory test at every 16 weeks []

4. ECG at every 16 weeks []

Secondary Outcome Measures

1. On time based on patient diary (up to 104 weeks) []

2. UPDRS score at every 16 weeks []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	East Hanover	New Jersey	United States	07936

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00237263
• Other Study ID Numbers: CCOM998A1204
• First Posted: Oct 12, 2005
• Last Update Posted: Feb 23, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Novartis: Parkinson's disease, end-of -dose wearing-off, entacapone
• Additional relevant MeSH terms: Parkinson Disease; Entacapone

Study Results

No Results Posted as of Feb 23, 2017