BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS (HAROSA1)

Bioprojet

Status and phase: Completed; Phase 3

Conditions: Excessive Daytime Sleepiness; Obstructive Sleep Apnea

Treatments: Drug: BF2.649; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01071876

2009-017248-14 (EudraCT Number)

P09-08 / BF2.649

Details and patient eligibility

About

Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.

This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.

Full description

The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo.

The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.

Enrollment: 244 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with OSA treated by nCPAP but still complaining with EDS
• ESS score > or = 12

Exclusion criteria

• patient suffering from insomnia without OSA
• co-existing narcolepsy
• patient with sleep debt not due to OSA
• acute or chronic severe disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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244 participants in 2 patient groups, including a placebo group

BF2.649

Experimental group

Description:

BF2.649 capsules dosed at 5mg, 10 mg, 20mg

Treatment:

Drug: BF2.649

Placebo

Placebo Comparator group

Description:

Capsules of Placebo containing lactose with low, medium and high dosage

Treatment:

Drug: Placebo