Evidence map›Paper›PMID 33864229›Full record

ArticleNeurology and therapy2021

Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson's Disease and Dyskinesia.

Shyamal H Mehta, Rajesh Pahwa, Caroline M Tanner, Robert A Hauser, Reed Johnson

2 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 17% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Excessive Daytime Sleepiness in Parkinson's Disease.Nature and science of sleep · 2022
    Review
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

5 authors at 5 institutions in 1 country.

Shyamal H MehtaDepartment of Neurology, Mayo Clinic-Scottsdale, 13400 East Shea Blvd, Scottsdale, AZ, 85254, USA. mehta.shyamal@mayo.edu.
Rajesh PahwaDepartment of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.
Caroline M TannerDepartment of Neurology, University of California, San Francisco, CA, USA.
Robert A HauserUSF Parkinson's Disease and Movement Disorders Center Parkinson Foundation Center of Excellence, University of South Florida, Tampa, FL, USA.
Reed JohnsonAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Adamas Pharmaceuticals (United States) · USFoundation Center · USMayo Clinic in Arizona · USUniversity of California, San Francisco · USUniversity of Kansas Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGocovri (amantadine) extended release capsules are approved for treatment of dyskinesia and as a levodopa adjunct for OFF episodes in patients with Parkinson's disease (PD). We report treatment-related effects on non-motor symptoms (NMS) assessed as secondary outcomes in two trials using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I.

methodsEASE LID and EASE LID 3 enrolled levodopa-treated patients with PD and ≥ 1 h/day ON time with troublesome dyskinesia. Patients were randomized to Gocovri (274 mg) or placebo taken daily at bedtime. Treatment differences from baseline to week 12 in MDS-UPDRS Part I were evaluated for the pooled population (N = 196) from both trials. Correlation analyses of NMS (MDS-UPDRS Part I) with dyskinesia using Unified Dyskinesia Rating Scale (UDysRS) scores were performed.

resultsFor changes in the MDS-UPDRS Part I items, the treatment difference favored Gocovri in daytime sleepiness (P = 0.006) and depression (P = 0.049) scores, but favored placebo in cognitive impairment (P = 0.038), and  hallucinations and psychosis (P < 0.001) scores. The treatment difference for the changes in total Part I score was -0.8, favoring Gocovri (P = 0.22). At baseline, MDS-UPDRS Part I modestly correlated with UDysRS score (r +0.25, P < 0.001), and improvement in NMS correlated with improvement in dyskinesia at week 12 for Gocovri (r +0.39, P < 0.001) but not placebo (r +0.12, P = 0.29). The most commonly reported adverse events for Gocovri were hallucination (21%); dizziness, dry mouth, and peripheral edema (16% each); and constipation, falls, and orthostatic hypotension (13% each).

conclusionThis post hoc analysis shows potential benefit with Gocovri treatment for the NMS of daytime sleepiness and depression in dyskinetic PD patients. Overall, improvement in NMS scores correlated with improvement in dyskinesia.

trial registrationClinicalTrials.gov identifiers: NCT02136914 and NCT02274766.

Indexed as

AmantadineDepressionDepressive disorderDyskinesiasHallucinationsParkinson’s diseaseSleep

Identifiers

PMID33864229
PMCPMC8140024
OpenAlexW3153563356

What OpenQuestion holds

Textmetadata
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.