Amantadine ER Capsules for Levodopa-Induced Dyskinesia in Parkinson Disease



Title: ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson Disease (EASE LID Study)

Pahwa, R et al.


 

What You Need to Know:

Administration of ADS-5012 (amantadine) at bedtime may be effective the treatment of levodopa-induced dyskinesia (LID) in Parkinson disease (PD) and also reduces OFF time.

Trial Design:

  • Double-blind, placebo-controlled, multicenter study evaluated the safety and efficacy of ADS-5102 in the treatment of LID in PD
  • 126 patients were randomized to receive ADS-5102 (274mg extended-release oral capsule) at bedtime or placebo for up to 25 weeks
  • Primary endpoint: change in the Unified Dyskinesia Rating Scale score from baseline to week 12 for ADS-5102 compared to placebo
  • Secondary endpoint: OFF time
  • Primary endpoint analyzed using the modified intention-to-treat population; safety analyses included all patients who received ADS-5102 or placebo

Key Outcomes:

  • Modified intention-to-treat population: 121 patients
  • “At week 12, the least-squares mean (SE) change in the Unified Dyskinesia Rating Scale score was -15.9 (1.6) for ADS-5102 (n=63) and -8.0 (1.6) for placebo (n=58) (treatment difference, -7.9, 95% CI, -12.5 to -3.3; P<0.001)”
  • Mean (SE) OFF time decreased by 0.6 (0.3) hours for ADS-5012-treated patients and increased by 0.3 (0.3) hours for patients receiving placebo (treatment difference: -0.9 hours; 95% CI: -1.6, -0.2; P=0.02)
  • Commonly reported adverse events (% ADS-5012 patients vs placebo, respectively): visual hallucinations (23.8% vs 1.7%), peripheral edema (23.8% vs 0%), dizziness (22.2% vs 0%)
  • 20.6% of ADS-5102 patients discontinued treatment due to adverse events vs 6.9% of placebo patients