Session Information
Date: Monday, September 23, 2019
Session Title: Clinical Trials, Pharmacology and Treatment
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: To investigate the safety and efficacy of continuous treatment with 50 mg Opicapone (OPC) for 1 year after treatment with a placebo, 25 mg or 50 mg of OPC in Japanese Parkinson’s Disease (PD) patients (pts) with end-of-dose motor fluctuation being treated with L-dopa/DCI.
Background: This comfort-PD study consisted of 2 parts, a double-blind (DB) part where pts were administered a placebo, 25 mg or 50 mg of OPC, and an open-label (OL) extension part where pts received a 50 mg dose of OPC. OPC is a long-acting COMT inhibitor that shows clinically sustained inhibition of COMT activity with once daily dosing. This study was conducted to investigate the safety profile when a fixed OPC dose of 50 mg was continuously administered for 1 year to Japanese PD pts.
Method: All pts who completed the DB part could transfer to the OL part, and all transferred pts were given a fixed OPC dose of 50 mg and varying doses of L-dopa/DCI or anti-PD drugs based on individual response for 1 year. Adverse events (AEs), including physical examinations, vital sign, laboratory tests and ECG, and the reduction in OFF time from the DB baseline, were evaluated for 1 year.
Results: Total 391 pts were transferred to the OL part after completion of the DB part, and approximately 80% completed the 1-year study. AEs were reported in 338 (86.4%) pts; among these pts, adverse reactions (ADRs) related to the investigational drug were reported in 156 (39.9%) pts. Frequent AEs included epipharyngitis (16.9%) and dyskinesia (12.0%), but the most frequent ADR was dyskinesia (11.5%). Serious ADRs and ADRs leading to discontinuation were infrequent and occurred in 10 (2.6%) and 11 (2.8%) pts, respectively. The OFF time reduction was maintained over 1 year, and the mean change in OFF time from the DB baseline was -106.68 minutes at 28 weeks of the OL part, and it was -101.89 minutes at 52 weeks. Of note, when switched from placebo to 50 mg of OPC, the OFF time sharply decreased.
Conclusion: When a fixed 50 mg dose of OPC administered with a varying dose of L-dopa/DCI or anti-PD drugs to Japanese PD pts with end-of dose motor fluctuation, OPC was well tolerated for 1 year. Additionally, OPC had a lasting effect with a stable OFF time reduction.
To cite this abstract in AMA style:
A. Takeda, R. Takahashi, Y. Tsuboi, M. Nomoto, T. Maeda, A. Nishimura, N. Hattori. An open-label, 1-year extension clinical study in Japan of Opicapone treatment for Parkinson’s disease -Comfort-PD study part 2 [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/an-open-label-1-year-extension-clinical-study-in-japan-of-opicapone-treatment-for-parkinsons-disease-comfort-pd-study-part-2/. Accessed May 19, 2025.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/an-open-label-1-year-extension-clinical-study-in-japan-of-opicapone-treatment-for-parkinsons-disease-comfort-pd-study-part-2/