Objective: Characterize the long-term safety and tolerability of 340 mg of ADS-5102 administered once daily at bedtime, for the treatment of LID in Parkinson’s disease (PD), including subjects with LID with prior deep brain stimulation (DBS).

Background: Treatment of LID in PD is an unmet need. There are no approved drug therapies. The efficacy of ADS-5102 for treating LID has been demonstrated in three randomized, placebo-controlled trials.

Methods: In an ongoing open-label safety study conducted in US and Western Europe (NCT02202551), PD subjects with LID receive 340 mg of ADS-5102 once daily at bedtime for up to two years. Eligible subjects include those with LID with prior DBS and those continuing or initiating ADS-5102 treatment following their participation in a prior placebo-controlled studies (EASED, EASE LID or EASE LID 3).  PD medications, including levodopa preparations, were allowed to change during the study. The primary outcome measure is safety and tolerability. Efficacy is assessed using the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Part IV.

Results: 223 subjects received ADS-5102 for a mean duration of 395 days (range: 2–721). The most common adverse events (AEs) included fall (26%), visual hallucinations (20%), constipation (13%), and peripheral edema (13%). Thirty-one subjects (14%) discontinued dosing due to an AE; Discontinuations due to AEs were lower in those subjects that had previously received ADS-5102 in the placebo-controlled studies than those that received placebo (4 vs.16 subjects, respectively). For the cohort of subjects enrolled from the 25-week EASE LID study, an approx. 6 unit reduction in the mean MDS-UPDRS, Part IV score was seen in both treatment groups (baseline score of approx. 12) up to Week 64 in the EASE LID 2 study. A similar effect was seen for enrolled EASE LID 3 subjects. For those subjects that entered the study with prior DBS, the mean reduction from baseline to Week 64 was 4.4 in MDS-UPDRS, Part IV. These effects were achieved without compromising the underlying control of PD symptoms.  

Conclusions: ADS-5102 was generally well tolerated across all groups and AEs are consistent with the safety data reported from previous ADS-5102 studies. ADS-5102 maintained long-term efficacy in the treatment of LID, including subjects with prior DBS.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/interim-results-of-an-ongoing-open-label-safety-study-of-ads-5102-amantadine-hydrochloride-extended-release-capsules-for-treatment-of-levodopa-induced-dyskinesia-lid-ease-lid-2-study/