Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2015
Time to response with sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.
- Cognitive Impairment Following Clinical or Recreational Use of Gammahydroxybutyric Acid (GHB): A Systematic Review.Current neuropharmacology · 2022Pooled it
- Enhancing sleep slow waves with auditory stimulation in people with Parkinson's disease: a randomized proof-of-concept trial.Scientific reports · 2026Trial
- Review
- Dosing Optimization of Low-Sodium Oxybate in Narcolepsy and Idiopathic Hypersomnia in Adults: Consensus Recommendations.Neurology and therapy · 2024Article
- Article
- [Real-life WAKE study in narcolepsy patients with cataplexy treated with pitolisant and unresponsive to previous treatments].Revista de neurologia · 2022Observational
- Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia.Nature and science of sleep · 2022Article
- Clinical Characteristics of Cataplectic Attacks in Type 1 Narcolepsy.Current neurology and neuroscience reports · 2020Review
- Therapeutic Strategies for Mitigating Driving Risk in Patients with Narcolepsy.Therapeutics and clinical risk management · 2020Review
- Article
- Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment.Nature reviews. Neurology · 2019Review
- Recent advances in treatment for narcolepsy.Therapeutic advances in neurological disorders · 2019Review
- Article
- Correlation of Changes in Patient-Reported Quality of Life With Physician-Rated Global Impression of Change in Patients With Narcolepsy Participating in a Clinical Trial of Sodium Oxybate: A Post Hoc Analysis.Neurology and therapy · 2017Article
- Longitudinal assessment of excessive daytime sleepiness in early Parkinson's disease.Journal of neurology, neurosurgery, and psychiatry · 2017Observational
- The Medical and Economic Burden of Narcolepsy: Implications for Managed Care.American health & drug benefits · 2017Review
- Safety and efficacy of long-term use of sodium oxybate for narcolepsy with cataplexy in routine clinical practice.Sleep medicine · 2017Article
- Cataplexy and Its Mimics: Clinical Recognition and Management.Current treatment options in neurology · 2017Review
- Evaluation of Quality of Life in Patients With Narcolepsy Treated With Sodium Oxybate: Use of the 36-Item Short-Form Health Survey in a Clinical Trial.Neurology and therapy · 2016Article
- Pharmacological management of narcolepsy and cataplexy in pediatric patients.Paediatric drugs · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesThis post hoc analysis evaluated the time to response that can be expected with sodium oxybate (SXB) for treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy.
methodsData were from a 4-week, double-blind, randomized, placebo-controlled trial (GHB-2; N = 136) of oral SXB 3 g, 6 g, and 9 g nightly, and its 12-month open-label extension (GHB-3). Two response definitions were utilized: ≥ 20% improvement in Epworth Sleepiness Scale (ESS) score (EDS responders), and ≥ 50% reduction in weekly cataplexy attacks (cataplexy responders). These thresholds were previously determined to be clinically relevant based on analysis of the relationship of Clinical Global Impression of Change with ESS and number of cataplexy attacks. Kaplan-Meier curves and median times to first response, based on above criteria, and to maximum response were estimated.
resultsAmong 86 patients randomized to SXB in GHB-2 and continued into GHB-3, 77.6% and 90.7% were EDS and cataplexy responders, respectively. The median (95% CI) times to first response were 37 (31-50) days for EDS and 25 (17-29) days for cataplexy, and median times to maximum response were 106 (85-164) days for EDS and 213 (94-279) days for cataplexy. GHB-3 results among 31 patients initially randomized to placebo were consistent with those treated with SXB throughout, but with longer times to maximum response.
conclusionsResponse onset, assessed as clinically meaningful improvements in EDS and cataplexy, was observed in most patients within 2 months; a longer period is needed to achieve maximum response. Clinicians should recognize that time to initial and maximum response may take weeks to months.
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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.