Session Information
Date: Thursday, June 23, 2016
Session Title: Parkinson's disease: Clinical trials, pharmacology and treatment
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: Evaluate the safety of opicapone (OPC) in Parkinson’s disease patients with motor fluctuations enrolled in the 1-year extension of study BIPARK I.
Background: OPC, a new once-daily COMT inhibitor, was shown to be safe and effective in the treatment of motor fluctuations in Parkinson’s disease patients in two large, pivotal, multinational trials (BIPARK I and II). Here we present the safety results of the 1-year extension of study BIPARK I.
Methods: After completing the double-blind (DB) part of the BIPARK I study, 495 patients continued to a 1-year open-label (OL) extension, in which all subjects were to receive flexible doses of OPC (25-mg OPC QD for 1-week; then investigator could freely adjust the levodopa therapy and/or OPC [5, 25 or 50-mg] according to clinical response). Safety was assessed by adverse events (AEs), laboratory, vital-signs, ECG, physical and neurological examinations, modified Minnesota Impulsive Disorders Interview (mMIDI) and Columbia Suicide Severity Rating Scale (C-SSRS).
Results: A total of 432 (87.3%) subjects completed the 1-year OL treatment period. The most common reported AEs (≥ 5% of patients) were dyskinesia (14.5%), drug effect decreased (12.1%) and Parkinson’s disease (worsening) (6.7%). The majority of AEs were mild to moderate in intensity. Serious AEs were reported in few patients (9.7%). Eleven deaths occurred, none considered related to treatment. There were no reports of urine discoloration, severe diarrhea or severe hepatic events. Few significant findings were observed for laboratory, vital-signs, physical and neurological examinations or ECG readings. The mMIDI showed no indication of increased risk of impulsive disorders. The C-SSRS showed no effect on suicidality.
Conclusions: Long-term use of OPC once-daily over 1-year was safe and well-tolerated with no new or unexpected safety concerns.
To cite this abstract in AMA style:
A. Santos, J. Ferreira, A. Lees, F. Stocchi, O. Rascol, N. Lopes, H. Gama, J.F. Rocha, P. Soares-da-Silva. Safety of opicapone in fluctuating Parkinson’s disease patients: Results of the 1-year extension of study BIPARK I [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/safety-of-opicapone-in-fluctuating-parkinsons-disease-patients-results-of-the-1-year-extension-of-study-bipark-i/. Accessed June 14, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-of-opicapone-in-fluctuating-parkinsons-disease-patients-results-of-the-1-year-extension-of-study-bipark-i/