Minimum effective dose-finding study of BF2.649, in patients with moderate to severe Obstructive Sleep Apnea, experiencing Excessive Daytime Sleepiness (EDS) despite regular use of nCPAP, and patients having refused this therapy. Randomized, double blind study with BF2.649 (5-, 10-, 20-, 40- mg/d), or placebo

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019413-25-FR

Enrollment

120

Registered

2010-06-04

Start date

2010-06-28

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of excessive daytime sleepiness associated to obstructive sleep apnea MedDRA version: 12.1 Level: LLT Classification code 10055577 Term: Obstructive sleep apnea syndrome

Interventions

Product Name: Pitolisant Product Code: BF2.649 Pharmaceutical Form: Capsule* INN or Proposed INN: BF 2.649 (Pitolisant) Concentration unit: mg milligram(s) Concentration type: range Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients having been submitted to nCPAP therapy for a minimum period of 3 months, and still complaining of Excessive Daytime Sleepiness despite the efforts made beforehand to obtain an efficient nCPAP therapy on Excessive Daytime Sleepiness (EDS) (group A) - Patients with OSA, complaining of Excessive Daytime Sleepiness but refusing to be treated by nCPAP therapy (group B) - Epworth score = 11 - Patients having signed the informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patient suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders, but without OSA (ICSD 2005): Patient with narcolepsy - sleep debt not due to OSA (according to the physician‘s judgment) – non respiratory sleep fragmentation (Periodic legs movement…) - Patient suffering from a psychiatric disease - Severe comorbid medical or biological conditions that may jeopardize study participation at the discretion of the investigator - Positive beta HCG pregnant test or breast-feeding women - Women with child-bearing potential and no efficient birth-control method - Patient unable to understand and comply with the study protocol -Positive serology testes – HCV – HBsAg and HIV (optional)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and the safety of BF2.649 on the excessive daytime sleepiness in OSA patients and to determine the minimum effective dose (MED);Secondary Objective: - To assess the percentage of responders to treatment - To evaluate the reduction of sleepiness and sleep episodes on the sleep diary - To assess the Improvement in CGI (Assessment of illness severity) ;Primary end point(s): Epworth Sleepiness Scale scores (ESS) on the 14-day treatment period	—

Measure

Time frame

Main Objective: To evaluate the efficacy and the safety of BF2.649 on the excessive daytime sleepiness in OSA patients and to determine the minimum effective dose (MED);Secondary Objective: - To assess the percentage of responders to treatment - To evaluate the reduction of sleepiness and sleep episodes on the sleep diary - To assess the Improvement in CGI (Assessment of illness severity) ;Primary end point(s): Epworth Sleepiness Scale scores (ESS) on the 14-day treatment period

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026