Jed Black1, Todd Swick2, Richard Bogan3, Chinglin Lai4, Lawrence P Carter5. 1. Jazz Pharmaceuticals, Palo Alto, CA, USA; Stanford Sleep Medicine Center, Redwood City, CA, USA. Electronic address: Jed.Black@jazzpharma.com. 2. Neurology and Sleep Medicine Consultants of Houston, Houston, TX, USA. 3. University of South Carolina School of Medicine, Columbia, SC, USA; SleepMed, Inc., Columbia, SC, USA; Medical University of South Carolina, Charleston, SC, USA. 4. Jazz Pharmaceuticals, Palo Alto, CA, USA. 5. Jazz Pharmaceuticals, Palo Alto, CA, USA; University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Abstract
BACKGROUND: Effects of sodium oxybate (SXB) on patients with narcolepsy with cataplexy (NC) or without cataplexy (NWOC) have not been separately evaluated in clinical trials. METHODS: Retrospective analysis evaluated data from a phase 3, randomized, placebo-controlled trial of SXB, modafinil, and SXB + modafinil versus placebo in adult NC patients (n = 95) or NWOC patients (n = 127). NC patients were identified based on medical history, concomitant medications, and sleep-onset REM periods on nocturnal polysomnography. The studied outcomes were changes from baseline at eight weeks on the Epworth Sleepiness Scale (ESS), the Maintenance of Wakefulness Test (MWT), and the Clinical Global Impression of Change (CGI-C). RESULTS: Among NC and NWOC patients, ESS improvement was significantly greater with SXB and SXB + modafinil versus placebo. In NC patients, mean MWT sleep latency was significantly increased with SXB + modafinil versus placebo. In NWOC patients, mean MWT sleep latency significantly increased in all groups versus placebo. Higher percentages of patients in the SXB and SXB + modafinil groups were "very much improved" or "much improved" on the CGI-C versus placebo in both NC and NWOC populations, although the difference did not reach statistical significance in the NWOC populations. Adverse events were consistent with previously-reported profiles for modafinil and SXB. Nausea was more common in the SXB and SXB + modafinil groups. Dizziness and tremor were more common in the SXB + modafinil group only. CONCLUSIONS:SXB alone and in combination with modafinil improved subjective ratings of excessive sleepiness and an objective measure of the ability to stay awake to similar extents in NC patients and NWOC patients.
RCT Entities:
BACKGROUND: Effects of sodium oxybate (SXB) on patients with narcolepsy with cataplexy (NC) or without cataplexy (NWOC) have not been separately evaluated in clinical trials. METHODS: Retrospective analysis evaluated data from a phase 3, randomized, placebo-controlled trial of SXB, modafinil, and SXB + modafinil versus placebo in adult NC patients (n = 95) or NWOC patients (n = 127). NC patients were identified based on medical history, concomitant medications, and sleep-onset REM periods on nocturnal polysomnography. The studied outcomes were changes from baseline at eight weeks on the Epworth Sleepiness Scale (ESS), the Maintenance of Wakefulness Test (MWT), and the Clinical Global Impression of Change (CGI-C). RESULTS: Among NC and NWOC patients, ESS improvement was significantly greater with SXB and SXB + modafinil versus placebo. In NC patients, mean MWT sleep latency was significantly increased with SXB + modafinil versus placebo. In NWOC patients, mean MWT sleep latency significantly increased in all groups versus placebo. Higher percentages of patients in the SXB and SXB + modafinil groups were "very much improved" or "much improved" on the CGI-C versus placebo in both NC and NWOC populations, although the difference did not reach statistical significance in the NWOC populations. Adverse events were consistent with previously-reported profiles for modafinil and SXB. Nausea was more common in the SXB and SXB + modafinil groups. Dizziness and tremor were more common in the SXB + modafinil group only. CONCLUSIONS:SXB alone and in combination with modafinil improved subjective ratings of excessive sleepiness and an objective measure of the ability to stay awake to similar extents in NC patients and NWOC patients.
Authors: Bende Zou; William S Cao; Zhiwei Guan; Kui Xiao; Conrado Pascual; Julian Xie; Jingxi Zhang; James Xie; Frank Kayser; Craig W Lindsley; C David Weaver; Jidong Fang; Xinmin Simon Xie Journal: Sleep Date: 2019-03-01 Impact factor: 5.849
Authors: Chiraag Thakrar; Kishankumar Patel; Grainne D'ancona; Brian D Kent; Alexander Nesbitt; Hugh Selsick; Joerg Steier; Ivana Rosenzweig; Adrian J Williams; Guy D Leschziner; Panagis Drakatos Journal: J Sleep Res Date: 2017-10-19 Impact factor: 3.981
Authors: Panagis Drakatos; Dimosthenis Lykouras; Grainne D'Ancona; Sean Higgins; Nadia Gildeh; Raluca Macavei; Ivana Rosenzweig; Joerg Steier; Adrian J Williams; Rexford Muza; Brian D Kent; Guy Leschziner Journal: Sleep Med Date: 2017-05-06 Impact factor: 3.492