Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial

Phase 3

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Opicapone

• Registration Number: NCT01851850
• Lead Sponsor: Rabin Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-05
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-13
• Primary Completion: 2016-05-24
• Study Completion: 2016-05-24
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug	Opicapone	-

Primary Outcome Measures

Name	Time	Method
off periods	6 month	number of "off" periods during the day without worsening dyskinesia.

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tiqva, Hamerkaz, Israel