Evidence map›Paper›PMID 29532440›Full record

Trial reportCNS drugs2018

Pooled Analyses of Phase III Studies of ADS-5102 (Amantadine) Extended-Release Capsules for Dyskinesia in Parkinson's Disease.

Lawrence W Elmer, Jorge L Juncos, Carlos Singer, Daniel D Truong, Susan R Criswell, Sotirios Parashos, Larissa Felt, Reed Johnson, Rajiv Patni

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in CNS drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
4.8field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02136914 phase3completednot on this map

Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)

TypeinterventionalSponsorAdamas Pharmaceuticals, Inc.Ran2014 to 2015Enrolled126ConditionsDyskinesia, Levodopa Induced Dyskinesia (LID), Parkinson's DiseaseArmsADS-5102, Placebo
NCT02274766 phase3completednot on this map

ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)

TypeinterventionalSponsorAdamas Pharmaceuticals, Inc.Ran2014 to 2016Enrolled77ConditionsDyskinesia, Levodopa-Induced Dyskinesia (LID), Parkinson's Disease (PD)ArmsADS-5102, Placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.

  1. Interventions for preventing falls in Parkinson's disease.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Pooled it
  3. A Randomized, Double-Blind, Controlled Phase II Study of Foliglurax in Parkinson's Disease.Movement disorders : official journal of the Movement Disorder Society · 2022
    Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Levodopa treatment: impacts and mechanisms throughout Parkinson's disease progression.Journal of neural transmission (Vienna, Austria : 1996) · 2025
    Review
  12. Article
  13. Article
  14. AClinical parkinsonism & related disorders · 2025
    Article
  15. Review
  16. Amantadine use in the French prospective NS-Park cohort.Journal of neural transmission (Vienna, Austria : 1996) · 2024
    Article
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Lawrence W ElmerDepartment of Neurology, University of Toledo College of Medicine, 3120 Glendale Avenue, Toledo, OH, 43614, USA. Lawrence.Elmer@utoledo.edu.
Jorge L JuncosDepartment of Neurology and Movement Disorders, Emory University School of Medicine, Atlanta, GA, USA.
Carlos SingerDepartment of Neurology, University of Miami, Miami, FL, USA.
Daniel D TruongThe Parkinson's and Movement Disorder Institute, Fountain Valley, CA, USA.
Susan R CriswellDepartment of Neurology, Washington University, St. Louis, MO, USA.
Sotirios ParashosStruthers Parkinson's Center, Golden Valley, MN, USA.
Larissa FeltAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Reed JohnsonAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Rajiv PatniAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Adamas Pharmaceuticals (United States) · USEmory University · USParkinson's and Movement Disorder Institute · USUniversity of Miami · USUniversity of Toledo · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough levodopa is considered the most effective pharmacotherapy for motor symptoms of Parkinson's disease (PD), chronic use is associated with motor complications, including fluctuating response and unpredictable, involuntary movements called dyskinesia. ADS-5102 (amantadine) extended-release (ER) capsules (GOCOVRI

objectiveIn this study, we present pooled results from two randomized, double-blind, placebo-controlled, phase III ADS-5102 trials. PATIENTS AND

methodsThe two studies in PD patients with dyskinesia shared design and eligibility criteria, differing only in treatment duration. Results from common assessment time points were pooled.

resultsAt 12 weeks, the least squares (LS) mean change in total score on the Unified Dyskinesia Rating Scale among 100 patients randomized to ADS-5102 and 96 patients randomized to placebo was - 17.7 (standard error [SE] 1.3) vs. - 7.6 (1.3) points, respectively (- 10.1 points, 95% confidence interval [CI] - 13.8, - 6.5; p < 0.0001). The relative treatment difference between groups was 27.3% (p < 0.0001). At 12 weeks, the LS mean change in OFF time was - 0.59 (0.21) vs. +0.41 (0.20) h/day, a difference of - 1.00 h/day (95% CI - 1.57, - 0.44; p = 0.0006). For both efficacy measures, a significant difference from placebo was attained by two weeks, the first post-baseline assessment, and was maintained throughout 12 weeks. In the pooled ADS-5102 group, the most common adverse events were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.

conclusionsThese analyses provide further evidence supporting ADS-5102 as an adjunct to levodopa for treating both dyskinesia and OFF time in PD patients with dyskinesia. Clinicaltrials.gov identifier: NCT02136914 and NCT02274766.

Indexed as

AdultAgedAged, 80 and overAmantadineAntiparkinson AgentsCapsulesDelayed-Action PreparationsDouble-Blind MethodDyskinesia, Drug-InducedFemaleHumansMaleMiddle AgedParkinson DiseaseTreatment OutcomeAmantadineAntiparkinson AgentsCapsulesDelayed-Action Preparations

Identifiers

PMID29532440
PMCPMC5934466
OpenAlexW2789703631

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.