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Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease

NCT01036139 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2013-04-12

No results posted yet for this study

Summary

To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.

Conditions

Interventions

DRUG

BF2.649 (pitolisant)

1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D

Sponsors & Collaborators

Principal Investigators

  • Kati Gutierrez, PharmD · Bioprojet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • France

Study Locations

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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 NCT01036139 on ClinicalTrials.gov