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Clinical Trial Summary

This is a multicentric international phase III, double blind randomized study assessing efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on to sodium oxybate of narcoleptic patients with residual Excessive Daytime Sleepiness (EDS) during 8 weeks


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01789398
Study type Interventional
Source Bioprojet
Contact
Status Completed
Phase Phase 3
Start date September 2012
Completion date August 2014

See also
  Status Clinical Trial Phase
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Completed NCT02821715 - Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients Phase 2
Completed NCT01681121 - A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy Phase 2
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Enrolling by invitation NCT05113745 - A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy Phase 3
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
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