Objective: Evaluate the impulse control disorders reported as adverse events in phase III studies with opicapone (OPC) in fluctuating Parkinson’s disease patients.

Background: Impulse control disorders (ICDs) comprise a wide spectrum of abnormal behaviours which have been reported in association with the use of anti-Parkinson’s medication.

Methods: A post-hoc analysis of pooled data of the two pivotal studies of opicapone in fluctuating Parkinson’s disease patients (BIPARK I and II) and respective 1-year open-label extensions was performed. During the studies, ICDs were screened at regular intervals with the administration of the modified Minnesota Impulsive Disorders Interview. Any clinically relevant finding was to be reported as an adverse event. ICD adverse events were identified per the Preferred Terms (MedDRA dictionary) more consistent with the literature.

Results: A total of 951 patients treated with OPC were included in the analysis. ICD adverse events were reported in few subjects (n=14; 1.5%). Pathological gambling was the most frequent ICD (n=5), followed by hypersexuality (n=3), binge eating (n=2) and compulsive shopping (n=2). Non-specific events included impulsive behavior (n=3) and impulse-control disorder (n=2). Most cases were of mild to moderate severity. No serious ICDs were reported and OPC discontinuation was necessary in just 1 subject.

Conclusions: Impulse control disorders reported during OPC treatment were infrequent and no safety concern was detected.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/evaluation-of-impulse-control-disorders-in-fluctuating-parkinsons-disease-patients-under-opicapone-treatment/