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

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01851850
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 36.8
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: Opicapone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Continue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical Trial
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: May 24, 2016
• Actual Study Completion Date: May 24, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drug	Drug: Opicapone; 25mg or 50mg once per day

Outcome Measures

Primary Outcome Measures

1. off periods [6 month]

   number of "off" periods during the day without worsening dyskinesia.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petach Tiqva	Hamerkaz	Israel	49100

Sponsors and Collaborators

• Rabin Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT01851850
• Other Study ID Numbers: BIA-91067
• First Posted: May 13, 2013
• Last Update Posted: Mar 16, 2020
• Last Verified: Jan 1, 2013

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Rabin Medical Center: PD; Off periods; quality of life; dyskinesia; end-off-dose motor fluctuations
• Additional relevant MeSH terms: Parkinson Disease; Opicapone

Study Results

No Results Posted as of Mar 16, 2020