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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01851850
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Opicapone Phase 3

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Study Type : Interventional  (Clinical Trial)
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 2013
Actual Primary Completion Date : May 24, 2016
Actual Study Completion Date : May 24, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. off periods [ Time Frame: 6 month ]
    number of "off" periods during the day without worsening dyskinesia.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851850


Locations
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Israel
Rabin Medical Center
Petach Tiqva, Hamerkaz, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01851850    
Other Study ID Numbers: BIA-91067
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: January 2013
Individual Participant Data (IPD) Sharing Statement:
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:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Opicapone
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents