Evidence map›Paper›PMID 28777755›Full record

ArticleJournal of Parkinson's disease2017

ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease (EASE LID 2 Study): Interim Results of an Open-Label Safety Study.

Robert A Hauser, Rajesh Pahwa, Caroline M Tanner, Wolfgang Oertel, Stuart H Isaacson, Reed Johnson, Larissa Felt, Mary Jean Stempien

Registry-linked trialAbstract read
In one paragraph

Article in Journal of Parkinson's disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02202551 (Open-Label Safety Study of ADS-5102), which is not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
–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.

NCT02202551 phase3completednot on this map

Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)

TypeinterventionalSponsorAdamas Pharmaceuticals, Inc.Ran2014 to 2018Enrolled223ConditionsDyskinesia, Levodopa Induced Dyskinesia (LID), Parkinson's Disease (PD)ArmsADS-5102
3 · Its place in the literature

Who cites it

26 citing papers in PubMed.

  1. Trial
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  5. The anti-dyskinetic effect of the clinic-ready mGluRNaunyn-Schmiedeberg's archives of pharmacology · 2025
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  15. The mGluJournal of neural transmission (Vienna, Austria : 1996) · 2020
    Article
  16. Combined mGluJournal of neural transmission (Vienna, Austria : 1996) · 2020
    Article
  17. Article
  18. Review
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  20. Article
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

8 authors.

Robert A HauserUniversity of South Florida, Tampa, FL, USA.
Rajesh PahwaUniversity of Kansas Medical Center, Kansas City, KS, USA.
Caroline M TannerUniversity of California San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.
Wolfgang OertelPhilipps University, Marburg, Germany.
Stuart H IsaacsonParkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.
Reed JohnsonAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Larissa FeltAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Mary Jean StempienAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMedical treatment of levodopa-induced dyskinesia (LID) in Parkinson's disease (PD) is an unmet need. ADS-5102 (amantadine) extended-release capsules is being developed for the treatment of LID in patients with PD.

objectiveEvaluate the long-term safety and tolerability of 274 mg ADS-5102 for LID in PD.

methodsIn an ongoing, open-label safety study (NCT02202551), PD patients with LID received 274 mg of ADS-5102 once daily at bedtime. Patients were recruited from previous ADS-5102 trials. In addition, patients were enrolled who were ineligible for previous ADS-5102 trials due to previous implantation of deep-brain stimulation (DBS) devices. The primary outcome measure was safety assessed through adverse events (AEs). Efficacy was assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part IV and its subparts.

resultsFor this interim analysis, 223 patients received ADS-5102 for a mean duration of 348 (SD 182) days. The most common AEs included falls (25.1%), visual hallucinations (19.3%), peripheral edema (13.0%), and constipation (12.6%). Overall, 32 patients (14.3%) discontinued due to an AE. In patients receiving placebo in previous studies, the mean MDS-UPDRS, Part IV scores decreased by 3.4 points from baseline (n = 78) to week 8 and remained stable through week 64 (n = 21). In patients receiving ADS-5102 in previous studies, the mean baseline (n = 61) MDS-UPDRS, Part IV score was low due to the response to ADS-5102 in previous studies and remained stable through week 64 (total of 88 weeks; n = 21). The effect was primarily due to reduction in item 4.2 (functional impact of dyskinesia) and item 4.4 (functional impact of motor fluctuations).

conclusionsADS-5102 was generally well tolerated in all groups, including DBS patients, and the safety profile was consistent with previous controlled studies. Long-term durability and tolerability were shown from the double-blind studies through participation in the open-label study up to 88 weeks.

Indexed as

AgedAmantadineDouble-Blind MethodDrug Delivery SystemsDyskinesia, Drug-InducedFemaleHumansKaplan-Meier EstimateLevodopaMaleMiddle AgedTreatment OutcomeAmantadineLevodopaamantadinedyskinesialevodopa-induced dyskinesiaParkinson’s disease

Identifiers

PMID28777755
PMCPMC5611804

What OpenQuestion holds

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LicenceCC BY-NC
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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.