Evidence map›Paper›PMID 28833562›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2017

Randomized, placebo-controlled trial of ADS-5102 (amantadine) extended-release capsules for levodopa-induced dyskinesia in Parkinson's disease (EASE LID 3).

Wolfgang Oertel, Karla Eggert, Rajesh Pahwa, Caroline M Tanner, Robert A Hauser, Claudia Trenkwalder, Reinhard Ehret, Jean Philippe Azulay, Stuart Isaacson, Larissa Felt and 1 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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15 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Wolfgang OertelPhilipps University, Marburg, Germany.
Karla EggertPhilipps University, Marburg, Germany.
Rajesh PahwaUniversity of Kansas Medical Center, Kansas City, Kansas, USA.
Caroline M TannerUniversity of California San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, California, USA.
Robert A HauserUniversity of South Florida, Tampa, Florida, USA.
Claudia TrenkwalderParacelsus-Elena-Klinik, Kassel and Clinic Neurosurgery, University Medical Center, Goettingen, Germany.
Reinhard EhretPraxis Neurologie, Berlin, Germany.
Jean Philippe AzulayHôpital de la Timone, Marseille, France.
Stuart IsaacsonParkinson's Disease and Movement Disorders Center, Boca Raton, Florida, USA.
Larissa FeltAdamas Pharmaceuticals, Inc., Emeryville, California, USA.
Mary Jean StempienAdamas Pharmaceuticals, Inc., Emeryville, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe treatment of levodopa-induced dyskinesia in Parkinson's disease (PD) is an unmet need with no approved drug therapy.

objectiveThe purpose of this study was to investigate the efficacy and safety of 274 mg ADS-5102 (amantadine) extended-release capsules (equivalent to 340-mg amantadine HCl) for levodopa-induced dyskinesia in a randomized controlled trial.

methodsPD patients with ≥1 hour of troublesome dyskinesia and at least mild functional impact were randomized to placebo or ADS-5102 once daily at bedtime for 13 weeks. The primary efficacy analysis was based on change from baseline to week 12 on the Unified Dyskinesia Rating Scale total score in the modified intent-to-treat population. OFF time was a key secondary measure.

resultsAt week 12, least-squares mean change in the Unified Dyskinesia Rating Scale was -20.7 (standard error 2.2) for ADS-5102 (n = 37) and -6.3 (standard error 2.1) for placebo (n = 38; treatment difference -14.4, 95% confidence interval -20.4 to -8.3, P < .0001), indicating improvement in levodopa-induced dyskinesia. OFF time decreased 0.5 hours (standard error 0.3) for ADS-5102 from a baseline mean of 2.6 hours and increased 0.6 hours (standard error 0.3) for placebo from a baseline mean of 2.0 hours (treatment difference -1.1 hours, 95% confidence interval -2.0 to -0.2, P = .0199). The most common adverse events (ADS-5102 versus placebo) included dry mouth (13.5% versus 2.6%), nausea (13.5% versus 2.6%), decreased appetite (10.8% versus 0%), insomnia (10.8% versus 0%), orthostatic hypotension (10.8% versus 0%), constipation (8.1% versus 0%), falls (8.1% versus 5.3%), and visual hallucinations (8.1% versus 5.3%). Adverse events led to treatment discontinuation in 19% versus 8%, respectively.

conclusionADS-5102 274 mg is an oral pharmacotherapy demonstrating a significant decrease in levodopa-induced dyskinesia and improving OFF time. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Indexed as

AdultAgedAged, 80 and overAmantadineAntiparkinson AgentsDelayed-Action PreparationsDouble-Blind MethodDyskinesia, Drug-InducedFemaleHumansLevodopaMaleMiddle AgedParkinson DiseaseRetrospective StudiesSeverity of Illness IndexAmantadineAntiparkinson AgentsDelayed-Action PreparationsLevodopaamantadinelevodopa-induced dyskinesiaParkinson's diseaserandomized controlled trialUnified Dyskinesia Rating Scale

Identifiers

PMID28833562
PMCPMC5763269

What OpenQuestion holds

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Registered trials

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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.