Objective: To assess patient outcomes and adverse events in Parkinson’s disease (PD) patients treated with Gocovri® (amantadine) extended release capsules at bedtime for dyskinesia, by age subgroups.

Background: Gocovri is the only medication shown to decrease dyskinesia in PD patients, while also reducing OFF time. Gocovri phase 3 trials enrolled PD patients with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2. No dose adjustment is recommended on the basis of age, however, elderly patients are more likely to have decreased renal function. Among patients with renal impairment, a lower initial (68.5 mg) and maximum dosage is reccomended in moderate renal impairment (up to 137 mg) or severe renal impairment (68.5 mg).

Method: Two pivotal, placebo-controlled, phase 3 studies of similar design were pooled in this subgroup analysis and subjects were stratified by their age at baseline (<65, 65-74, or ≥75 years of age). A mixed-effect model repeated measure (MMRM) analysis was performed on PD patient diary data for each age subgroup. Safety data were also analyzed.

Results: Of the 198 patients receiving study drug, 90 (45.4%) were under 65 years of age, 78 (39.4%) were between 65 and 74 years of age, and 30 (15.2%) were 75 years of age or older. For each age group, respectively, baseline mean ON time with troublesome dyskinesia was 4.9, 5.2, and 4.3 hours, and mean OFF time was 3.3, 2.2, and 2.4 hours. At Week 12, the respective least square mean placebo-corrected treatment differences for ON time with troublesome dyskinesia were -1.7, -1.3, and -1.0 hours, and for OFF time were -0.9, -1.3, and -0.5 hours. The corresponding increases in ON time without troublesome dyskinesia were 3.0, 2.4, and 1.9 hours. The most common adverse events (AEs) amongst Gocovri-treated patients were dizziness (23%) in the <65 group, hallucination (32%) in the 65-74 group, and falls and hallucination (27% each) in the ≥75 age group.

Conclusion: The treatment effect was consistent across age subgroups, with AEs occurring more frequently in the elderly population.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/the-efficacy-and-safety-of-gocovri-based-on-age-special-population-analyses-of-a-phase-3-study-program/