Objective: Improvement of off time and increase of ON time without dyskinesias at 6 months compared to the baseline situation. Secondary Endpoints: Determine the rate of change of ON time with / without disabling dyskinesias, motor symptoms, life quality and adverse effects.

Background: Retrospective observational study that assesses the efficacy in clinical practice of Opicapona as an alternative to patients with motor fluctuations from early and late phases.

Method: The data were obtained from medical records and the patients who had a previous UPDRS scale with a minimum of 3 years of disease evolution and fluctuations at least 3 months prior to the start of the drug and with stable doses of medication were included. Also, PDQ39 and PGCI scales were used.

Results: N: 25 patients, 55% was male, 6.56 years of evolution (3-14.5), H&Y 2.77 (1.5-3), 85% of patients had wearing off only.
Comparison of 6 months against the baseline situation: Reduction of the daily dose and equivalent daily dose of levodopa in 146.2mg / day and 192.7 mg / day respectively.
Reduction of the off time from 203.8 to 139.7 (64.1 min), increase of ON time in 77.3 min, increase of ON time without disabling dyskinesia in 42.8 min, change in UPDRSIII from 26.52 / 19.5 points at baseline, improvement in PDQ39 scale of 15.6 points and  4.3 points in PGCI.

In sub-analysis the fluctuators at 3 years and those who had advanced Parkinson’s disease with second-line therapies observing a reduction of LDD of 258.6 / 415.7mg/day respectively and the reduction of the OFF time in 83.7 / 42.4 min, therefore increase in ON time without disabling dyskinesia of 41 /75min.

EA:  8/25 patients (40%) were mild-moderate with hallucinations and dyskinesia being the most frequent. This happened in patients with previously took AD / SSRI / amantadine, the withdrawal rate due to AEs was 12% (general malaise, hallucinations and confusion) and due to lack of efficacy 6%.

Conclusion: A reduction of the off time was achieved in 64 min and ON time increase in 77 min, improvement in 42 min in on Time without disabling dyskinesias. Its benefit was marked in patients with few years of motor fluctuations as well as advanced Parkinson’s with second line therapy, maintaining a rate of adverse events similar at pivotal studies with a good tolerance and adherence to treatment.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/opicapone-study-in-daily-clinical-practice-opra-study/