Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: A double-blind, placebo-controlled study in 228 patients

Mansoor Ahmed, Claudio Bassetti, Philip Becker, Biber Michael, Jed Black, Richard Bogan, Andrew Chesson, James Cook, Stephen Duntley, Helene Emsellem, Milton Ermine, Roza Hayduk, Neil Feldman, John Fleming, Peter Geisler, Martha Hagaman, Dennis Hill, William C. Houghton, Carl S. Hornfeldt, Aatif M. HusainThomas Kaelin, Gert Jan Lammers, D. Alan Lankford, Judith Leech, Mortimer Mamelak, Geert Mayer, Harvey Moldofsky, Jacques Montplaisir, Rachel Morehouse, Adam Moscovitch, Sona Nevsimalova, Karel Sonka, William Orr, Ralph Pascualy, Vernon Pegram, Thomas Perkins, Jayant Phadke, Ruzica Ristanovic, John Shneerson, James Stevens, Todd Swick, Joyce Walsleben, Timothy Walter, J. Catesby Ware, Patrick Whitten, David Winslow

Research output: Contribution to journalArticlepeer-review

147 Citations (Scopus)

Abstract

Background and purpose: To measure the effect of the nocturnal administration of sodium oxybate on cataplexy in patients with narcolepsy. Patients and methods: This trial was conducted with 228 adult narcolepsy/cataplexy patients in 42 sleep clinics. Patients using anticataplectic medications were weaned from these medications, then randomized to receive 4.5, 6 or 9 g sodium oxybate nightly or placebo for 8 weeks. Patients receiving 6 and 9 g doses were titrated to their final dose in weekly 1.5 g increments. Placebo patients underwent a randomized mock dose-titration schedule. The effect of sodium oxybate on weekly cataplexy attacks was measured using patient daily diaries. Results: Compared to placebo, nightly doses of 4.5, 6 and 9 g sodium oxybate for 8 weeks resulted in statistically significant median decreases in weekly cataplexy attacks of 57.0, 65.0 and 84.7%, respectively. The decrease in cataplexy at the 4.5 g dose represents a novel finding. The weekly increase in sodium oxybate dose was associated with fewer adverse events than previously reported in double-blind sodium oxybate trials using fixed doses. Some adverse events reported demonstrated a clear dose-response relationship. Conclusions: In the largest study of its kind, sodium oxybate was highly effective for the treatment of cataplexy. The improvements in cataplexy are dependant on the dosage of sodium oxybate as well on the duration of treatment. Weekly dose titration appears to be well-tolerated.

Original languageEnglish
Pages (from-to)415-421
Number of pages7
JournalSleep Medicine
Volume6
Issue number5
DOIs
Publication statusPublished - Sept 2005
Externally publishedYes

Bibliographical note

Funding Information:
This study was sponsored by Orphan Medical, Inc, Minnetonka, MN.

ASJC Scopus Subject Areas

  • General Medicine

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