Oertel W, et al. – Physicians designed this randomized controlled trial to examine the efficacy and safety of 274 mg ADS–5102 (amantadine) extended–release capsules (equivalent to 340–mg amantadine HCl) for levodopa–induced dyskinesia. In levodopa–induced dyskinesia, ADS–5102 274 mg was an oral pharmacotherapy showing a significant decrease. It also improved OFF time.

• The physicians randomized PD patients with ≥1 hour of troublesome dyskinesia and at least mild functional impact to placebo or ADS-5102 once daily at bedtime for 13 weeks.
• The initial efficacy analysis was based on change from baseline to week 12 on the Unified Dyskinesia Rating Scale total score in the modified intent-to-treat population.
• A key secondary measure was OFF time.

• For ADS-5102 (n = 37), least-squares mean change in the Unified Dyskinesia Rating Scale was -20.7 (standard error 2.2) and -6.3 (standard error 2.1) for placebo (n = 38; treatment difference -14.4, 95% confidence interval -20.4 to -8.3, P < .0001) at week 12, showing improvement in levodopa-induced dyskinesia .
• For ADS-5102, OFF time decreased 0.5 hours (standard error 0.3) from a baseline mean of 2.6 hours and increased 0.6 hours (standard error 0.3) for placebo from a baseline mean of 2.0 hours (treatment difference -1.1 hours, 95% confidence interval -2.0 to -0.2, P = .0199).
• Dry mouth (13.5% vs. 2.6%), nausea (13.5% vs. 2.6%), decreased appetite (10.8% vs. 0%), insomnia (10.8% vs. 0%), orthostatic hypotension (10.8% vs. 0%), constipation (8.1% vs. 0%), falls (8.1% vs. 5.3%), and visual hallucinations (8.1% vs. 5.3%) were included as the most common adverse events (ADS-5102 vs. placebo).
• Due to adverse events treatment discontinuation occurred in 19% vs. 8%, respectively.