MedicalResearch.com Interview with:
Rajesh Pahwa MD
Department of Neurology
University of Kansas Medical Center, Kansas City, KS,
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Dyskinesia are one of the major unmet needs in Parkinson Disease patients. At the present time there are no approved medication for dyskinesia, however immediate release amantadine is used in PD patients with dyskinesia. ADS-5102 is a long acting, extended release capsule formulation of amantadine HCl administered once daily at bedtime. This study investigated the safety, efficacy and tolerability of ADS-5102 in Parkinson’s disease (PD) patients with levodopa-induced dyskinesia.
This was a randomized, double-blind, placebo-controlled study of Parkinson’s disease patients with levodopa-induced dyskinesia. In total, 126 patients were randomized to placebo or 274 mg ADS-5102 administered orally at bedtime. ADS-5102 was associated with a significant reduction in dyskinesia at 12 weeks compared with placebo, as measured by the mean change in Unified Dyskinesia Rating Scale (treatment difference, –7.9; P =.0009). OFF time was significantly reduced in ADS-5102 patients compared to placebo (treatment difference -0.9 hours, p=.017).
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: In Parkinson Disease patients with dyskinesia, ADS-5102 reduced the duration and severity of dyskinesia during the day and also reduced the number of hours that they were in the OFF state during the day.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: One of the interesting questions that this study raises is that if ADS-5102 is used early, before the onset of dyskinesia, can it delay the onset of dyskinesia and OFF periods in Parkinson Disease patients.
Disclosures: I am a consultant for ADAMAS and was on the steering committee member and have received personal compensation from Adamas.
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Pahwa R, Tanner CM, Hauser RA, Isaacson SH, Nausieda PA, Truong DD, Agarwal P, Hull KL, Lyons KE, Johnson R, Stempien MJ. ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson Disease (EASE LID Study)A Randomized Clinical Trial. JAMA Neurol. Published online June 12, 2017. doi:10.1001/jamaneurol.2017.0943
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