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

March 12, 2020 updated by: Rabin Medical Center

Continue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Hamerkaz
      • Petach Tiqva, Hamerkaz, Israel, 49100
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
off periods
Time Frame: 6 month
number of "off" periods during the day without worsening dyskinesia.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 24, 2016

Study Completion (Actual)

May 24, 2016

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 13, 2013

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIA-91067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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