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A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy.
Sleep. 2003 Feb 01; 26(1):31-5.S

Abstract

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.

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12627729

Citation

"A 12-month, Open-label, Multicenter Extension Trial of Orally Administered Sodium Oxybate for the Treatment of Narcolepsy." Sleep, vol. 26, no. 1, 2003, pp. 31-5.
A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003;26(1):31-5.
(2003). A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep, 26(1), 31-5.
A 12-month, Open-label, Multicenter Extension Trial of Orally Administered Sodium Oxybate for the Treatment of Narcolepsy. Sleep. 2003 Feb 1;26(1):31-5. PubMed PMID: 12627729.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. PY - 2003/3/12/pubmed PY - 2003/5/2/medline PY - 2003/3/12/entrez SP - 31 EP - 5 JF - Sleep JO - Sleep VL - 26 IS - 1 N2 - 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. SN - 0161-8105 UR - https://www.unboundmedicine.com/medline/citation/12627729/A_12_month_open_label_multicenter_extension_trial_of_orally_administered_sodium_oxybate_for_the_treatment_of_narcolepsy_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=12627729.ui DB - PRIME DP - Unbound Medicine ER -