Ahmed, Mansoor and Becker, Philip and Biber, Michael and Black, Jed and Bogan, Richard and Chesson, Andrew and Cook, James and Duntley, Stephen and Emsellem, Helene and Chase, Chevy and Erman, Milton and Hayduk, Roza and Feldman, Neil and Fleming, John and Geisler, Peter and Hagaman, Martha and Hill, Dennis and Houghton, William C. and Hornfeldt, Carl S. and Husain, Aatif M. and Kaelin, Thomas and Lammers, Gert Jan and Lankford, D. Alan and Leech, Judith and Mamelak, Mortimer and Mayer, Geert and Moldofsky, Harvey and Montplaisir, Jacques and Morehouse, Rachel and Moscovitch, Adam and Nevsimalova, Sonka and Orr, William and Pascualy, Ralph and Pegram, Vernon and Perkins, Thomas and Phadke, Jayant and Ristanovic, Ruzica and Shneerson, John and Stevens, James and Swick, Todd and Walsleben, Joyce and Walter, Timothy and Ware, J. Catesby and Whitten, Patrick and Winslow, David (2005) A Double-Blind, Placebo-Controlled Study Demonstrates Sodium Oxybate Is Effective for the Treatment of Excessive Daytime Sleepiness in Narcolepsy. JOURNAL OF CLINICAL SLEEP MEDICINE, 1 (4). pp. 391-397. ISSN 1550-9389, 1550-9397
Full text not available from this repository. (Request a copy)Abstract
Study Objective: Assess the efficacy of sodium oxybate for the treatment of narcolepsy with an emphasis on excessive daytime sleepiness. Design: Eight-week, multicenter, double-blind, placebo-controlled trial. Setting: Forty-two sleep clinics in the United States, Canada, and Europe. Participants: Two hundred twenty-eight adults with narcolepsy with cataplexy. Interventions: Patients were withdrawn from antidepressant treatment and then randomly assigned to receive 4.5 g, 6 g, or 9 g of sodium oxybate nightly or placebo for 8 weeks. Six-gram and 9-g doses were titrated in weekly 1.5-g increments. Patients who were receiving placebo underwent a mock dose-titration schedule. Stimulant use continued unchanged. Excessive daytime sleepiness was measured using the Epworth Sleepiness Scale and Maintenance of Wakefulness Test. The Clinical Global Impression of Change was used to measure changes in disease severity. Changes in narcolepsy symptoms and adverse events were recorded in daily diaries. Results: After 8 weeks, patients treated with 9 g of sodium oxybate nightly displayed a significant median increase of > 10 minutes in the Maintenance of Wakefulness Test (p < .001). Patients displayed dose-related decreases in median Epworth Sleepiness Scale scores and frequency of weekly inadvertent naps, which were significant at the 6-g and 9-g doses (for each, p < .001). The improvements in excessive daytime sleepiness were incremental to those achieved by concomitant stimulants alone. Significant improvements in the Clinical Global Impression of Change were noted for each group treated with sodium oxybate (p = .001). Adverse events were consistent with the known safety profile of sodium oxybate. Conclusions: When combined with its previously demonstrated anticataplectic effects, the results of the current study indicate sodium oxybate is the first drug to demonstrate efficacy for the 2 major symptoms of narcolepsy.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ; Maintenance of wakefulness test; epworth sleepiness Scale; excessive daytime sleepiness; narcolepsy; sodium oxybate; gamma-hydroxybutyrate |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 07 Jun 2021 10:53 |
| Last Modified: | 07 Jun 2021 10:53 |
| URI: | https://pred.uni-regensburg.de/id/eprint/36729 |
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