MedTrace Logo

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

NCT01072968 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2015-01-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BF2.649

1 capsule per day in the morning before the breakfast

DRUG

Placebo

1 capsule per day in the morning before the breakfast

Sponsors & Collaborators

Principal Investigators

  • Evelyne De Paillette, MD · Bioprojet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01072968 on ClinicalTrials.gov