NCT00642928

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

Randomized, Dose-finding Study of BF 2.649 5, 10 20 and 40 mg/d in Comparison to Placebo in Excessive Daytime Sleepiness in Parkinson's Disease Patients (PD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by resting tremor, rigidity, bradykinesia and loss of postural reflexes that affects 1% of the North American population. Besides these motor problems there are also so called non-motor problems. Excessive daytime sleepiness (EDS) is a bothersome non-motor problem, which affects 20% to 50% of all PD patients and currently, there isn't any registered treatment for that trouble. The study medication BF2.649 tested here is a novel, highly potent, selective, orally active inverse agonist at the histamine H3 receptor, therefore strengthens histaminergic transmission in the brain and increases wakefulness EDS is characterized by daytime somnolence and sudden sleep episodes. This problem has several consequences, e.g., an impairment of quality of life, an interference with activities of daily living and other handicaps in the management of social and family affairs. The primary endpoint of this study will be measured by the change in the well-validated Epworth sleepiness scale (ESS). The ESS is a simple self-administered 8-item questionnaire. The outcome is to get an impression about the level of the daytime sleepiness in several real-life situations. On the basis of this pharmacological and clinical rationale it is considered relevant to carry out a dose-finding study for this original, non-amphetamine molecule in PD patients affected by excessive daytime sleepiness. PD severity will be assessed by the routinely used UPDRS.

Conditions

• Excessive Daytime Sleepiness
• Parkinson's Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-03-01
• Completion: 2009-06-01
• First posted: 2008-03-25
• Last updated: 2012-06-11

Locations

1 site across 1 country: France