Document Detail


A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy.
MedLine Citation:
PMID:  12627729     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: To evaluate the long-term safety and efficacy of nightly sodium oxybate for the treatment of narcolepsy.
DESIGN: A multicenter, 12-month, open-label trial.
PARTICIPANTS: 118 narcolepsy patients previously enrolled in a 4-week double-blind sodium oxybate trial.
INTERVENTIONS: Patients were administered 6 g sodium oxybate nightly, taken in equally divided doses at bedtime and 2.5 to 4 hours later. The study protocol permitted the dose to be increased or decreased in 1.5-g increments at 2-week intervals based on efficacy response or adverse experiences but staying within the range of 3 to 9 g nightly.
MEASURES: Narcolepsy symptoms and adverse events were recorded in daily diaries. Safety measures included physical and laboratory examinations repeated at 6 and 12 months. The primary efficacy measure was the change in weekly cataplexy attacks from baseline. Secondary measures included daytime sleepiness using the Epworth Sleepiness Scale (ESS), inadvertent naps/sleep attacks, nighttime awakenings, and the overall change in disease severity as rated by the investigators (Clinical Global Impression of Change; CGI-c).
RESULTS: Sodium oxybate, in doses of 3 to 9 g nightly, produced overall improvements in narcolepsy symptoms, which were significant at 4 weeks and maximal after 8 weeks. Reported improvements included a significant decrease in frequency of cataplexy attacks (p < 0.001); diminished daytime sleepiness (p < 0.001); and patient descriptions of nocturnal sleep quality, level of alertness, and ability to concentrate (for each p < 0.001). Adverse events were generally mild and patients showed no evidence of tolerance.
CONCLUSION: Sodium oxybate is an effective and well-tolerated treatment for narcolepsy.
Authors:
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Sleep     Volume:  26     ISSN:  0161-8105     ISO Abbreviation:  Sleep     Publication Date:  2003 Feb 
Date Detail:
Created Date:  2003-03-11     Completed Date:  2003-05-01     Revised Date:  2014-07-28    
Medline Journal Info:
Nlm Unique ID:  7809084     Medline TA:  Sleep     Country:  United States    
Other Details:
Languages:  eng     Pagination:  31-5     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adjuvants, Anesthesia / administration & dosage,  therapeutic use*
Adolescent
Adult
Aged
Double-Blind Method
Drug Administration Schedule
Female
Humans
Male
Middle Aged
Narcolepsy / drug therapy*
Prospective Studies
Sodium Oxybate / administration & dosage,  therapeutic use*
Chemical
Reg. No./Substance:
0/Adjuvants, Anesthesia; 502-85-2/Sodium Oxybate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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