Completed PHASE3 INTERVENTIONAL 2-arm NCT01789398

Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) (HARMONY IV)

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

Sponsor: Bioprojet

Conditions Narcolepsy

Interventions BF2.649

Updated 5 times since 2017 Last updated: Nov 17, 2015 Started: Sep 30, 2012 Primary completion: Aug 31, 2014 Completion: Aug 31, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Narcolepsy and is currently completed. Bioprojet leads this study, which shows 5 recorded versions since 2012 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Sep 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bioprojet

Data source: Bioprojet

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Montpellier, France