A 12-week open-label, multicenter study evaluating the safety and patient-reported efficacy of sodium oxybate in patients with narcolepsy and cataplexy
dc.contributor.author | Mamelak, Mortimer | |
dc.contributor.author | Swick, Todd | |
dc.contributor.author | Emsellem, Helene | |
dc.contributor.author | Montplaisir, Jacques-Yves | |
dc.contributor.author | Lai, Chinglin | |
dc.contributor.author | Black, Jed | |
dc.date.accessioned | 2018-09-07T18:28:53Z | |
dc.date.available | NO_RESTRICTION | fr |
dc.date.available | 2018-09-07T18:28:53Z | |
dc.date.issued | 2015 | |
dc.identifier.uri | http://hdl.handle.net/1866/20864 | |
dc.publisher | Elsevier | fr |
dc.subject | Attention | fr |
dc.subject | Cataplexy | fr |
dc.subject | Efficacy | fr |
dc.subject | Excessive daytime sleepiness | fr |
dc.subject | Narcolepsy | fr |
dc.subject | Open-label | fr |
dc.subject | Patient-reported outcomes | fr |
dc.subject | Safety | fr |
dc.subject | Sleep quality | fr |
dc.subject | Sodium oxybate | fr |
dc.title | A 12-week open-label, multicenter study evaluating the safety and patient-reported efficacy of sodium oxybate in patients with narcolepsy and cataplexy | fr |
dc.type | Article | fr |
dc.contributor.affiliation | Université de Montréal. Faculté de médecine. Département de psychiatrie et d'addictologie | fr |
dc.identifier.doi | 10.1016/j.sleep.2014.10.004 | |
dcterms.abstract | Objective: This study aimed to evaluate safety and efficacy of sodium oxybate (SXB) titrated to effect. Methods: SXB-naive patients who had participated in a randomized SXB clinical trial and had not been titrated to adequate clinical effect were initiated on open-label SXB at 4.5 g/night and titrated in 1.5-g increments to 6, 7.5, or 9 g/night or down to 3 g/night, based on individual clinical response. Treatment was 12 weeks; safety was the primary outcome. Efficacy was evaluated using the Narcolepsy Symptom Assessment Questionnaire (NSAQ), a five-point scale (“much improved” to “much worse”) that assessed changes from baseline in specific symptoms. Response was defined as “much improved” or “somewhat improved” overall at weeks 6 and 12. Results: Of 202 patients, 171 (85%) completed treatment; final doses were 3 g (n = 5), 4.5 g (n = 29), 6 g (n = 80), 7.5 g (n = 66), and 9 g (n = 22). Adverse events (AEs) were reported in 114 patients (56%), serious AEs in five (2%). The most common AEs were nausea (10%), headache (7%), and dizziness (5%). Response rate was 92% at week 6 and 90% at week 12; most patients reported improvements in all individual symptoms. Overall, 60% of patients rated their symptoms at 12weeks as “much improved,” and this improvement was dose dependent. Conclusions: The SXB safety profile was consistent with parent trials. Ninety percent of patients reported improvements as measured by the NSAQ. | fr |
dcterms.isPartOf | urn:ISSN:1389-9457 | fr |
dcterms.isPartOf | urn:ISSN:1878-5506 | fr |
dcterms.language | eng | fr |
UdeM.ReferenceFournieParDeposant | Mamelak, M., Swick, T., Emsellem, H., Montplaisir, J., Lai, C. & Black, J. (2015) A 12-week open-label, multicenter study evaluating the safety and patient-reported efficacy of sodium oxybate in patients with narcolepsy and cataplexy. Sleep Medicine, 16(1), 52-58. | fr |
UdeM.VersionRioxx | Version publiée / Version of Record | fr |
oaire.citationTitle | Sleep medicine | |
oaire.citationVolume | 16 | |
oaire.citationIssue | 1 | |
oaire.citationStartPage | 52 | |
oaire.citationEndPage | 58 |
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