PT - JOURNAL ARTICLE AU - Pahwa, Rajesh AU - Tanner, Caroline AU - Hauser, Robert AU - Isaacson, Stuart AU - Johnson, Reed AU - Felt, Larissa AU - Stempien, Mary Jean TI - Pooled Analysis of Phase 3 studies of ADS-5102 (amantadine hydrochloride) extended release capsules for Levodopa-Induced Dyskinesia: A detailed review of UDysRS Results (S56.003) DP - 2017 Apr 18 TA - Neurology PG - S56.003 VI - 88 IP - 16 Supplement 4099 - http://n.neurology.org/content/88/16_Supplement/S56.003.short 4100 - http://n.neurology.org/content/88/16_Supplement/S56.003.full SO - Neurology2017 Apr 18; 88 AB - Objective: Data from two Phase 3 clinical studies investigating the efficacy and safety of ADS-5102 in Parkinson’s disease (PD) patients with levodopa-induced dyskinesia (LID) were pooled to summarize results for the shared primary endpoint, Unified Dyskinesia Rating Scale (UDysRS) and its sub-components.Background: ADS-5102 (amantadine hydrochloride) extended release capsules is being developed for the treatment of LID in patients with PD. LID is characterized by involuntary movements during waking hours that are non-rhythmic, purposeless, unpredictable and occur as a result of chronic levodopa use.Design/Methods: EASE LID (NCT02136914) and EASE LID 3 (NCT02274766) were Phase 3, randomized, placebo-controlled trials of identical design except for longer treatment duration in EASE LID. The UDysRS was assessed by neurologists. The time points common to both studies (Baseline, Weeks 2, 8, and 12) were used for the pooled evaluations.Results: At Week 12, the LS mean change from baseline in UDysRS total score was -17.7 for the ADS-5102 group and7.6 for the placebo group (P<0.0001), indicating a significant improvement in LID with ADS-5102 compared to placebo. The LS mean change from baseline for the UDysRS total historical score was -10.7 for the ADS-5102 group and -5.1 for the placebo group (P<0.0001). The LS mean change from baseline for the UDysRS total objective score was -7.0 for the ADS-5102 group and -2.5 for the placebo group (P<0.0001). Lastly, for any change from baseline in the UDysRS total score, a greater proportion of patients taking ADS-5102 showed a reduction compared to placebo. The most common adverse reactions (≥ 5% in active) included visual hallucinations, dry mouth, and dizziness.Conclusions: A significant reduction in UDysRS total score was seen at Week 12 in the pooled analysis, which was driven by an effect on both the historical (patient-reported) and objective (physician-assessed) scores.Study Supported by:This study was sponsored by Adamas Pharmaceuticals, Inc.Disclosure: Dr. Pahwa has received personal compensation for activities with AbbVie, ACADIA, Acorda, Adamas, Cynapses, Global Kinetics, Lundbeck, Neurocrine, Pfizer, Sage, Teva Neuroscience and US World Meds as a consultant. Dr. Pahwa has received personal compensation in an editorial capacity for the International Journal of Neuroscience. Dr. Pahwa has received research support from AbbVie, Adamas, Avid, Biotie, Boston Scientific, Civitas, Cynapses, Kyowa, National Parkinson Foundation, NIH/NINDS, Parkinson Study Group, and Pfizer. Dr. Tanner has received personal compensation for activities with Adamas, Neurocrine, Ultragenyx Pharmaceuticals, Cynapsus Pharmaceuticals, Biotie Pharmaceuticals, and INTEC Pharma as a consultant or a data monitoring service member. Dr. Hauser has received personal compensation for activities with Guidepoint Global, SAI-Mmed Partners, Scienomics Group, Gerson Lehrman Group, LCN Consulting, Putnam Associates, National Parkinson Foundation, eResearch Technology, Inc., Lundbeck LLC, Krog & Partners, and Cynapsus as a consultant. Dr. Hauser has received licensing fee payments from the University of South Florida. Dr. Hauser has received research support from Abbvie Pharmaceutical Research and Development, Acadia Pharmaceuticals, Astra Zeneca, Biotie Therapies, Acorda Therapeutics, Inc., Civitas, Impax Pharmaceuticals, and Kyowa Kirin Pharma. Dr. Isaacson has nothing to disclose. Dr. Johnson has received personal compensation for activities with Adamas Pharmaceuticals, Inc as an employee. Dr. Felt has received personal compensation for activities with Adamas Pharmaceuticals, Inc. as an employee. Dr. Stempien has received personal compensation for activities with Adamas Pharmaceuticals, Inc. as a consultant.