MedTrace Logo

Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients

NCT00642928 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2012-06-11

No results posted yet for this study

Summary

The objective of this trial is to define the minimum effective dose of BF 2.649 between 5 mg, 10 mg, 20 mg or 40 mg versus placebo in reducing the Excessive Daytime Sleepiness of Parkinson's disease patients

Conditions

Interventions

DRUG

Placebo

1 capsule per day during 4 weeks

DRUG

BF 2.649 5 mg

one BF 2.649 capsule of 5 mg per day during 4 weeks

DRUG

BF 2.649 10 mg

One BF 2.649 capsule of 10 mg per day during 4 weeks

DRUG

BF 2.649 20 mg

One BF 2.649 capsule of 20 mg per day during 4 weeks

DRUG

BF 2.649 40 mg

One BF 2.649 capsule of 40 mg per day during 4 weeks

Sponsors & Collaborators

Principal Investigators

  • ARNULF Isabelle · Pitié-Salpêtrière Hospital, Paris, France

  • Carsten Moeller · Universitätsklinikum Giessen und Marburg, Marburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-03-31
Completion
2009-06-30

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 NCT00642928 on ClinicalTrials.gov