Evidence map›Paper›PMID 26094838›Full record

Trial reportAnnals of neurology2015

Clarithromycin in γ-aminobutyric acid-Related hypersomnolence: A randomized, crossover trial.

Lynn Marie Trotti, Prabhjyot Saini, Donald L Bliwise, Amanda A Freeman, Andrew Jenkins, David B Rye

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01146600 (Clarithromycin for the Treatment of Hypersomnia), which is 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
6.1field-weighted citation impact, top 3% 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.

NCT01146600 phase2completednot on this map

Clarithromycin for the Treatment of Hypersomnia

TypeinterventionalSponsorLynn Marie TrottiRan2010 to 2012Enrolled26ConditionsHypersomnia, Idiopathic Hypersomnia, NarcolepsyArmsClarithromycin followed by placebo, Placebo then Clarithromycin
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 97 citations in OpenAlex.

  1. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021
    Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Drug Interactions With Excessive Daytime Sleepiness Treatments.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2026
    Review
  6. Idiopathic hypersomnia is a 24-hour disorder.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Review
  7. Review
  8. Article
  9. Current knowledge on the pathophysiology of idiopathic hypersomnia and potential mechanisms of action for low-sodium oxybate treatment.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Review
  10. Pathophysiological Models of Hypersomnolence Associated With Depression.Biological psychiatry global open science · 2025
    Review
  11. Insights from a 10-year Australasian idiopathic hypersomnia patient data registry study.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Article
  12. Diagnostic challenges and burden of idiopathic hypersomnia: a systematic literature review.Sleep advances : a journal of the Sleep Research Society · 2024
    Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Idiopathic Hypersomnia and Other Hypersomnia Syndromes.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021
    Review
  19. Article
  20. Closed-Eye Visual Hallucinations Associated With Clarithromycin.The Journal of neuropsychiatry and clinical neurosciences · 2021
    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

6 authors at 1 institution in 1 country.

Lynn Marie TrottiDepartment of Neurology and Emory Sleep Center.
Prabhjyot SainiDepartment of Neurology and Emory Sleep Center.
Donald L BliwiseDepartment of Neurology and Emory Sleep Center.
Amanda A FreemanDepartment of Neurology and Emory Sleep Center.
Andrew JenkinsDepartment of Anesthesia, Emory University School of Medicine, Atlanta, GA.
David B RyeDepartment of Neurology and Emory Sleep Center.
Emory University · US

Funding

Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Sleepiness and sleep drunkenness: narcolepsy versus GABA-related hypersomniaK23NS083748 · NINDS · EMORY UNIVERSITY · PI TROTTI, LYNN MARIE · 2014 to 2018
$918k
NCATS NIH HHS UL1 TR000454NINDS NIH HHS K23 NS083748
6 · The paper itself

Abstract

objectiveSome central hypersomnolence syndromes are associated with a positive allosteric modulator of γ-aminobutyric acid (GABA)-A receptors in cerebrospinal fluid. Negative allosteric modulators of GABA-A receptors, including clarithromycin, have been reported to reduce sleepiness in these patients. We sought to systematically assess the effects of clarithromycin on objective vigilance and subjective sleepiness.

methodsThis was a 5-week, randomized, placebo-controlled, double-blind, crossover trial of clarithromycin 500mg with breakfast and lunch, in patients with hypersomnolence syndromes (excluding narcolepsy with cataplexy) and evidence for abnormal cerebrospinal fluid potentiation of GABA-A receptors. The study occurred at a university-affiliated medical center. The primary outcome measure was median reaction time on the psychomotor vigilance task (PVT) at week 2 in each condition. Secondary outcomes included the Epworth Sleepiness Scale, Stanford Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Pittsburgh Sleep Quality Index, SF-36, and additional PVT measures.

resultsTwenty-three patients began treatment. Three patients dropped out, and final analyses were performed on 20 complete cases. Median reaction time was not significantly different between clarithromycin and placebo. Subjective measures of sleepiness were significantly improved on clarithromycin versus placebo. Altered taste perception occurred, but was the only side effect more common on clarithromycin than placebo. No serious adverse events occurred.

interpretationSubjective sleepiness, but not psychomotor vigilance, improved during a 2-week course of clarithromycin. Although additional studies are needed, this suggests that clarithromycin may be a reasonable treatment option in patients with treatment-refractory hypersomnolence. This trial was registered at ClinicalTrials.gov (NCT01146600) and supported by the American Sleep Medicine Foundation.

Indexed as

AdultClarithromycinCross-Over StudiesDisorders of Excessive SomnolenceDouble-Blind MethodFemalegamma-Aminobutyric AcidHumansMaleMiddle AgedPsychomotor PerformanceReaction TimeYoung AdultClarithromycingamma-Aminobutyric Acid

Identifiers

PMID26094838
PMCPMC4732573
OpenAlexW2142062933

What OpenQuestion holds

Textmetadata
LicenceTDM
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.