Completed PHASE3 INTERVENTIONAL 2-arm NCT01072968

BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. (HAROSA2)

Efficacy and Safety of BF2.649 in Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea (OSA) Refusing the Nasal Continuous Positive Airway Pressure (nCPAP) Therapy

Sponsor: Bioprojet

Conditions Excessive Daytime Sleepiness Obstructive Sleep Apnea

Interventions BF2.649 Placebo

Updated 5 times since 2017 Last updated: Jan 20, 2015 Started: Oct 31, 2011 Primary completion: May 31, 2014 Completion: May 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 Excessive Daytime Sleepiness and Obstructive Sleep Apnea and is currently completed. Bioprojet leads this study, which shows 5 recorded versions since 2011 — 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

Oct 2011

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

• Grenoble, France