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

Bioprojet268 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

268

Conditions

Obstructive Sleep Apnea Excessive Daytime Sleepiness

Interventions

BF2.649DRUG

1 capsule per day in the morning before the breakfast

PlaceboDRUG

1 capsule per day in the morning before the breakfast

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with OSA still complaining EDS,refusing nCPAP * ESS score ≥ 12 Exclusion Criteria: * Patients suffering from insomnia without OSA * Co-existing narcolepsy * Patient with sleep debt not due to OSA * Acute or chronic severe disease

Locations (1)

Centre Hospitalier Universitaire de Grenoble

Grenoble, Grenoble, France

Outcomes

Primary Outcomes

ESS (Epworth Sleepiness Scale) change from baseline

Time frame: From baseline to week 12 and week 51

Data from ClinicalTrials.gov

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