Back to resultsContinuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Opicapone
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring PD, Off periods, quality of life, dyskinesia, end-off-dose motor fluctuations
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis with PD
- subjects who are willing to participate in the trial.
- subjects who participated in the BIA 9-1067-302 clinical trial.
Exclusion Criteria:
- subjects who didn't take part at the BIA 9-1067-302 clinical trial.
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug
Arm Description
Outcomes
Primary Outcome Measures
off periods
number of "off" periods during the day without worsening dyskinesia.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01851850
Brief Title
Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial
Official Title
Continue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 24, 2016 (Actual)
Study Completion Date
May 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to extend the use of opicapone 25 or 50mg once per day by subjects who participated in the BIA 9-1067-302 clinical trial according form 4a for additional three years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
PD, Off periods, quality of life, dyskinesia, end-off-dose motor fluctuations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Opicapone
Intervention Description
25mg or 50mg once per day
Primary Outcome Measure Information:
Title
off periods
Description
number of "off" periods during the day without worsening dyskinesia.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis with PD
subjects who are willing to participate in the trial.
subjects who participated in the BIA 9-1067-302 clinical trial.
Exclusion Criteria:
subjects who didn't take part at the BIA 9-1067-302 clinical trial.
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tiqva
State/Province
Hamerkaz
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial
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