Clinical trial
Double blind randomized study to assess the efficacy of BF2.649 compared to placebo in add-on to sodium oxybate in the treatment of narcoleptic patients with residual excessive daytime sleepiness (EDS) during 8 weeks.
To show relevant beneficial effect of BF2.649 on EDS compared to placebo in add on to sodium oxybate in narcoleptic patients with residual EDS.
This trial will characterize the efficacy of BF2.649 compared to placebo in showing an incremental improvement to the situation achieved by the use of sodium oxybate particularly in terms of a reduction of EDS as measured by the Epworth Sleepiness scale (ESS). In addition the change in the average number of cataplexy attacks per week will be assessed.
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Study start date | 2012-11-12 |