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Clinical Trial Summary

Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week).

The patients will be treated during 7 weeks with Pitolisant or placebo.


Clinical Trial Description

The treatment period (7 weeks double blind) will aim at demonstrating the efficacy of Pitolisant on the number of cataplexy attacks and the Excessive Daytime Sleepiness by verifying whether the results of Pitolisant are superior to those of placebo.

The safety will also be assessed. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01800045
Study type Interventional
Source Bioprojet
Contact
Status Completed
Phase Phase 3
Start date April 2013
Completion date January 2015

See also
  Status Clinical Trial Phase
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Completed NCT04923594 - Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy Phase 2
Completed NCT01072968 - BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. Phase 3
Completed NCT01620554 - Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA) Phase 2
Completed NCT01067235 - Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy Phase 3
Completed NCT00642928 - Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients Phase 2
Completed NCT00228566 - Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Enrolling by invitation NCT05113745 - A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy Phase 3
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Completed NCT01006122 - A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy Phase 2
Completed NCT02720744 - Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy Phase 3
Completed NCT03194217 - BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness Phase 2
Completed NCT01067222 - Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy Phase 3
Completed NCT00228553 - Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness Phase 3
Completed NCT04789174 - Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study Phase 4
Completed NCT05822128 - Alternative Epworth Sleepiness Scale ESS-ALT in French
Active, not recruiting NCT04886518 - Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1 Phase 2
Terminated NCT00620659 - Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015) Phase 2
Completed NCT01071876 - BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS Phase 3
Active, not recruiting NCT05458128 - A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia Phase 3