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Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy

ClinicalTrials.gov · COMPLETED, 2010

110 participants

Abstract

The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)

Conditions: Narcolepsy, Excessive Daytime Sleepiness, Cataplexy, Sleep Disorders.

Primary outcome: Epworth Sleepiness Scale (ESS).

Enrollment: 110 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 110 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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