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

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ClinicalTrials.gov Identifier: NCT01851850
Recruitment Status : Unknown
Verified January 2013 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 13, 2013
Last Update Posted : May 13, 2013
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: Non-Randomized
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
Estimated Primary Completion Date : May 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.



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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


Contacts
Contact: Ruth Djaldetti, Professor 972-3-9378218/9 ruthdjal@clalit.org.il
Contact: Yaniv Roditi, MSc 972-39236843 yar@clalit.org.il

Locations
Israel
Rabin Medical Center Not yet recruiting
Petach Tiqva, Hamerkaz, Israel, 49100
Principal Investigator: Ruth Djaldetti, Professor         
Sponsors and Collaborators
Rabin Medical Center

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01851850     History of Changes
Other Study ID Numbers: BIA-91067
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: January 2013

Keywords provided by Rabin Medical Center:
PD
Off periods
quality of life
dyskinesia
end-off-dose motor fluctuations

Additional relevant MeSH terms:
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