Evidence map›Paper›PMID 34191352›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2021

Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial.

Aleksandar Videnovic, Amy W Amara, Cynthia Comella, Paula K Schweitzer, Helene Emsellem, Kris Liu, Amanda L Sterkel, Mildred D Gottwald, Joshua R Steinerman, Philip Jochelson and 2 more

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 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.

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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
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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

12 authors at 7 institutions in 1 country.

Aleksandar VidenovicMovement Disorders Unit and Division of Sleep Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-9237-1516
Amy W AmaraDivision of Movement Disorders, Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Cynthia ComellaParkinson's Disease and Movement Disorders Program, Rush University, Chicago, Illinois, USA.
Paula K SchweitzerSleep Medicine and Research Center, St. Luke's Hospital, Chesterfield, Missouri, USA.
Helene EmsellemThe Center for Sleep & Wake Disorders, Chevy Chase, Maryland, USA.
Kris LiuJazz Pharmaceuticals, Palo Alto, California, USA.
Amanda L SterkelJazz Pharmaceuticals, Palo Alto, California, USA.
Mildred D GottwaldJazz Pharmaceuticals, Palo Alto, California, USA.
Joshua R SteinermanJazz Pharmaceuticals, Philadelphia, Pennsylvania, USA.
Philip JochelsonJazz Pharmaceuticals, Palo Alto, California, USA.
Katie ZomorodiJazz Pharmaceuticals, Palo Alto, California, USA.
Robert A HauserParkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA.ORCID 0000-0002-6369-1203
Jazz Pharmaceuticals (United States) · USCalifornia Center for Sleep Disorders · USMassachusetts General Hospital · USRush University · USSt. Luke's Hospital · USUniversity of Alabama at Birmingham · USUniversity of South Florida · US

Funding

Dystonia CoalitionU54NS065701 · NINDS · EMORY UNIVERSITY · PI JINNAH, HYDER A · 2009 to 2014
$7.0M
Exploratory study of different doses of endurance exercise in people with ParkinsR01NS074343 · NINDS · UNIVERSITY OF COLORADO DENVER · PI CORCOS, DANIEL M., SCHENKMAN, MARGARET L · 2011 to 2014
$3.0M
NINDS NIH HHS R01 NS074343NINDS NIH HHS U54 NS065701
6 · The paper itself

Abstract

backgroundSolriamfetol is approved (US and EU) for excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea.

objectivesEvaluate solriamfetol safety/efficacy for EDS in Parkinson's disease (PD).

methodsPhase 2, double-blind, 4-week, crossover trial: adults with PD and EDS were randomized to sequence A (placebo, solriamfetol 75, 150, 300 mg/d), B (solriamfetol 75, 150, 300 mg/d, placebo), or C (placebo). Outcomes (safety/tolerability [primary]; Epworth Sleepiness Scale [ESS]; Maintenance of Wakefulness Test [MWT]) were assessed weekly. P values are nominal.

resultsCommon adverse events (n = 66): nausea (10.7%), dizziness (7.1%), dry mouth (7.1%), headache (7.1%), anxiety (5.4%), constipation (5.4%), dyspepsia (5.4%). ESS decreased both placebo (-4.78) and solriamfetol (-4.82 to -5.72; P > 0.05). MWT improved dose-dependently with solriamfetol, increasing by 5.05 minutes with 300 mg relative to placebo (P = 0.0098).

conclusionsSafety/tolerability was consistent with solriamfetol's known profile. There were no significant improvements on ESS; MWT results suggest possible benefit with solriamfetol in PD. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Indexed as

Disorders of Excessive SomnolenceParkinson DiseaseAdultCarbamatesDouble-Blind MethodHumansPhenylalanineCarbamatesPhenylalaninesolriamfetolJZP-110Parkinson's diseasesleep-wake disordersSunositherapeutics

Identifiers

PMID34191352
PMCPMC8596433
OpenAlexW3177455150

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.