MedTrace Logo

Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

NCT01067222 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2012-06-11

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)

Conditions

Interventions

DRUG

BF2.649

BF2.649 oral capsules at 10 or 20 or 40 mg per day

DRUG

Modafinil

Modafinil oral capsules at 100 or 200 or 400 mg per day

DRUG

Placebo

Placebo oral capsules, 4 capsules per day

Sponsors & Collaborators

Principal Investigators

  • Claudio Bassetti · Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • Switzerland

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 NCT01067222 on ClinicalTrials.gov