Back to resultsAn 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
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Entacapone
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, end-of -dose wearing-off, entacapone
Eligibility Criteria
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.
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
Primary Outcome Measures
Incidence of adverse events during the long term treatment (maximum 3 years)
Blood pressure at every 12 weeks
Laboratory test at every 16 weeks
ECG at every 16 weeks
Secondary Outcome Measures
On time based on patient diary (up to 104 weeks)
UPDRS score at every 16 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00237263
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, end-of -dose wearing-off, entacapone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Entacapone
Primary Outcome Measure Information:
Title
Incidence of adverse events during the long term treatment (maximum 3 years)
Title
Blood pressure at every 12 weeks
Title
Laboratory test at every 16 weeks
Title
ECG at every 16 weeks
Secondary Outcome Measure Information:
Title
On time based on patient diary (up to 104 weeks)
Title
UPDRS score at every 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Learn more about this 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
We'll reach out to this number within 24 hrs