Continuation Treatment Protocol 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rabin Medical Center

Petach Tiqva, Central District, 49100, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opicapone

Drug

25mg or 50mg once per day

Primary outcomes

off periods

Time frame: 6 month

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

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: May 13, 2013
Registry last updated: Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed