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Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)

NCT01399606 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2017-01-31

No results posted yet for this study

Summary

This is a multicentric International Phase III,Long term open label study(12 months)assessing the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment of Excessive Daytime Sleepiness (EDS) in narcoleptic patients with or without cataplexy.

Conditions

Interventions

DRUG

BF2.649

5,10,20,or 40 mg per day, in a once daily scheme

Sponsors & Collaborators

Principal Investigators

  • Kati Gutierrez, PharmD · Bioprojet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-10-31
Completion
2016-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT01399606 on ClinicalTrials.gov