Parkinson’s disease patients treated with Gocovri (amantadine) experienced a 41 percent decrease in levodopa-induced dyskinesia compared to 14 percent of healthy people who took placebos.
That analysis of two Phase 3 trials are summarized in the study “Pooled Analyses of Phase III Studies of ADS-5102 (Amantadine) Extended-Release Capsules for Dyskinesia in Parkinson’s Disease,” published in the journal CNS Drugs.
“The results from this pooled analysis of two Phase 3 studies confirms the consistency of GOCOVRI’s benefit on dyskinesia and [off] time, as demonstrated in the individual studies across different Parkinson’s disease patient populations and all primary and secondary endpoint measures,” Lawrence W. Elmer, MD, PhD, of the University of Toledo, said in a press release. Elmer is the study’s lead author.
Researchers pooled the results of two trials — the EASE LID (NCT02136914) and the EASE LID 3 (NCT02274766 ) — that assessed the effectiveness of Adamas Pharmaceuticals’ Gocovri extended release capsules compared to placebo oral capsules in Parkinson’s disease patients with levodopa-induced dyskinesia, in which patients experience involuntary, jerky movements.
The trials’ design and eligibility criteria were the same in both Phase 3 trials, with the exception of treatment duration; in EASE LID patients underwent treatment for 25 weeks, and in EASE LID 3 the trial stopped at week 13. Gocovri was given once every night at bedtime.
Researchers pooled the trial’s results to analyze its primary goal, which assessed changes in the Unified Dyskinesia Rating Scale (UDysRS) score from baseline to week 12.
Additional parameters included changes in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), patient-reported Parkinson’s disease home diary data, and Clinician’s Global Impression of Change (CGI-C) in Overall PD Symptoms.
Gocovri led to a 41.1% reduction in dyskinesia from baseline to week 12 in the UDysRS score compared to 13.9% for the placebo group — a significant difference of 27.2%.
Also, dyskinesia and “off” time (period when medication is not working efficiently) also was improved, with patients achieving almost a four-hour improvement in “on” time without so-called “troublesome” dyskinesia.
By week 12, 25% of the patients treated with Gocovri had a complete resolution of off time compared to 14% in the placebo group.
Also, 68% of patients in the Gocovri group had an increase of more than two hours a day of on time without troublesome dyskinesia versus 40% in the placebo group. Moreover, 52% of patients treated with Gocovri had a complete resolution of on time with troublesome dyskinesia compared to only 23% of the placebo group.
“Patients take Gocovri once-daily at bedtime, which provides them with high amantadine concentrations upon waking and throughout the day when dyskinesia and [off] occur, and then lower concentrations in the evening when amantadine can disrupt sleep patterns. What’s most important from this pooled analysis, is that over half of patients treated with GOCOVRI reported a complete resolution of their [on] time with troublesome dyskinesia at 12 weeks,” he added.
The researchers believe these data show further evidence to support Gocovri as an adjunct to levodopa to treat both dyskinesia and off time in Parkinson’s patients with dyskinesia.
“With its demonstrated, consistent clinical efficacy, Gocovri finally provides a solution for physicians and patients needing a proven durable treatment for dyskinesia in people with Parkinson’s disease,” said Rajiv Patni, MD, chief medical officer of Adamas Pharmaceuticals, Inc.