Author Correction to: Pooled Analyses of Phase III Studies of ADS-5102 (Amantadine) Extended-Release Capsules for Dyskinesia in Parkinson’s Disease

Elmer, Lawrence; Juncos, Jorge L.; Singer, Carlos; Truong, Daniel D.; Criswell, Susan R.; Parashos, Sotirios A.; Felt, Larissa; Johnson, Raymond L.; Patni, Rajiv

doi:10.1007/s40263-018-0510-z

Cited by 5 publications

(10 citation statements)

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“…In the present open-label trial, PD patients completing double-blind, placebo-controlled Gocovri trials, and patients excluded from those trials because of DBS, began or continued once-daily Gocovri under conditions that more closely resemble realworld use. Over the 2 years of open-label treatment, Gocovri exhibited long-term safety, tolerability, and efficacy, consistent with the findings of double-blind trials lasting up to 25 weeks [4][5][6][7]12]. To our knowledge, this is now the longest-running trial to evaluate amantadine in PD patients with LID.…”

Section: Discussionsupporting

confidence: 70%

“…Therefore, we analyzed the incidence of AEs by baseline eGFR, and no clear relationship between baseline eGFR and AEs considered study drug-related was observed. In previously reported double-blind trials, there was a greater incidence of AEs such as hallucinations in patients with lower baseline eGFR [6,7]. Lack of observed relationship in this study may be explained in part by the long duration of EASE LID 2, during which many patients experienced some degree of reduction in eGFR from baseline.…”

Section: Discussioncontrasting

confidence: 57%

“…In phase 3 placebo-controlled trials lasting up to 25 weeks and enrolling approximately 200 PD patients, Gocovri 274 mg (corresponding to 340 mg of amantadine HCl) once daily at bedtime significantly reduced dyskinesia, with the additional benefit of significantly reducing OFF time. The Gocovri safety profile was consistent with the types of adverse events (AEs) known to occur with amantadine immediate-release (amantadine IR) treatment [4][5][6][7]. Based on these data, Gocovri was approved by the United States Food and Drug Administration in 2017, and is the only medication indicated for the treatment of dyskinesia in patients with PD receiving levodopa-based therapy, with or without concomitant dopaminergic medications.…”

Section: Introductionmentioning

confidence: 61%

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EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson’s Disease

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Pahwa

Hauser

et al. 2020

JPD

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Background: Gocovri ® (amantadine) extended release capsules are approved for the treatment of dyskinesia in patients with Parkinson's disease (PD) receiving levodopa-based therapy. Objective: To evaluate the long-term safety, tolerability, and efficacy of Gocovri in patients with PD experiencing levodopainduced dyskinesia. Methods: In this 2-year open-label trial, patients completing double-blind Gocovri clinical trials or excluded from prior trials because of deep-brain stimulation (DBS) received Gocovri 274 mg once daily at bedtime. The primary objective was to evaluate long-term safety and tolerability. In addition, dyskinesia and OFF time were assessed using Part IV (Motor Complications) scores on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Results: Among 223 enrolled patients (mean PD duration, 11.7 years; mean levodopa use, 9.3 years), 75.8% completed 1 year of treatment and 57.8% completed the trial, with a median treatment duration of 1.9 years. Common adverse events were fall (32.7%), hallucination (24.2%), peripheral edema (16.1%), constipation (13.5%), and urinary tract infection (10.3%); 31 patients (13.9%) discontinued because of adverse events considered related to study drug. At baseline, MDS-UPDRS Part IV scores were lower for patients continuing Gocovri (mean, 6.5 points) than for previous placebo (9.4) or DBS groups (10.5) but were similar for all groups by week 8 (6.3, 6.2, 6.4, respectively), and remained low for the duration of the trial (at week 100: 6.9, 7.3, 7.0, respectively). Conclusions: In patients with PD, Gocovri showed long-term safety and tolerability consistent with double-blind trial findings, and durable reduction in motor complications (dyskinesia and OFF time).

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Section: Discussionsupporting

confidence: 70%

Section: Discussioncontrasting

confidence: 57%

Section: Introductionmentioning

confidence: 61%

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EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson’s Disease

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Pahwa

Hauser

et al. 2020

JPD

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“…The safety profile of ADS-5102 has been reported for patients in individual ADS-5102 trials [23,24,33,34], including the two trials pooled here [23,24], and for the pooled population analyzed here [31]. The most commonly observed adverse reactions occurring at a frequency of > 10% and greater than placebo were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension [31,35]. The present analyses have limitations.…”

Section: Discussionmentioning

confidence: 96%

Impact of dyskinesia on activities of daily living in Parkinson's disease: Results from pooled phase 3 ADS-5102 clinical trials

Pahwa

Isaacson²,

Jimenez-Shaheed

et al. 2019

Parkinsonism & Related Disorders

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In Parkinson's disease, dyskinesias result from disease progression and chronic levodopa therapy. Using Unified Dyskinesia Rating Scale (UDysRS) data pooled from two pivotal trials of ADS-5102 (amantadine) extended-release capsules in dyskinetic patients, we assessed the impact of dyskinesia on activities of daily living (ADLs), and the effects of ADS-5102 versus placebo. Methods: Patients had troublesome dyskinesia (≥1 h/day) and at least mild functional impact of dyskinesia per Movement Disorder Society Unified Parkinson's Disease Rating Scale, Part IV, item 4.2. UDysRS Parts 1B, 3, and 4 scores at baseline were summarized descriptively. Twelve-week changes in score distributions and total scores were tested for significant differences between treatments. Results: Among 196 patients, the majority (63%-73%) characterized their dyskinesia at baseline as having at least a mild impact on walking and balance; public and social settings; exciting or emotional settings; doing hobbies and other activities; handwriting; and dressing (six of ten ADLs in UDysRS Part 1B). By clinician ratings (in Parts 3 and 4), greatest impairment was most often observed in the trunk (62% of patients) and occurred most often for the ADL of dressing (64% had at least moderate impairment). ADS-5102 significantly reduced the patient-rated impact of dyskinesia on six of ten ADLs in Part 1B, the clinician-rated intensity of dyskinesia in all seven body regions assessed in Part 3, and the clinician-rated disability during three of four ADL tasks assessed in Part 4. Improvements in Parts 1B, 3, and 4 total scores were also statistically significant. Conclusion: Dyskinesia can impair multiple tasks of daily living. Further studies may help characterize its underreported impact. By several measures, ADS-5102 treatment was associated with significant improvement of dyskinesias.

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“…Further data have also been generated from pooled analyses of the phase III EASE LID and EASE LID 3 studies focusing on efficacy and safety, 61,62 using a novel examination of diary events, 63 and activities of daily living, 16 in addition to a pharmacokinetic analysis of two phase I trials and the EASED study. 37 Together, these studies have provided extensive data on amantadine ER(Go) in patients with dyskinesia and OFF.…”

Section: The Amantadine Extended-release Gocovri Clinical Development Programmementioning

confidence: 99%

Development, Efficacy and Safety of Once-daily, Bedtime, Extended-release Amantadine (Gocovri®) to Treat Dyskinesia and OFF Time in Parkinson’s Disease

Isaacson¹,

Lyons²,

Amjad³

et al. 2021

Neurology

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Author Correction to: Pooled Analyses of Phase III Studies of ADS-5102 (Amantadine) Extended-Release Capsules for Dyskinesia in Parkinson’s Disease

Cited by 5 publications

References 0 publications

EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson’s Disease

EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson’s Disease

Impact of dyskinesia on activities of daily living in Parkinson's disease: Results from pooled phase 3 ADS-5102 clinical trials

Development, Efficacy and Safety of Once-daily, Bedtime, Extended-release Amantadine (Gocovri®) to Treat Dyskinesia and OFF Time in Parkinson’s Disease

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