drugset / Trial / NCT00642928

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

NCT00642928

Phase 2 Completed 108 enrolled Bioprojet
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2007-10
Primary completion
2009-03
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pitolisant Small molecule 5 mg Oral
Subject Pitolisant Small molecule 10 mg Oral
Subject Pitolisant Small molecule 20 mg Oral
Subject Pitolisant Small molecule 40 mg Oral