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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BF2.649 ( Pitolisant)

BF2.649 (5mg, 10 mg, 20 mg) in capsules

Group Type EXPERIMENTAL

BF2.649 (Pitolisant)

Intervention Type DRUG

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

Placebo

Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules

Group Type PLACEBO_COMPARATOR

BF2.649 (Pitolisant)

Intervention Type DRUG

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

Interventions

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BF2.649 (Pitolisant)

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

Intervention Type DRUG

Other Intervention Names

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Pitolisant

Eligibility Criteria

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Inclusion Criteria

* Patients with a documented history of Parkinson's disease according to UPDRS,fluctuator and non-fluctuator patients, Hoehn and Yahr score \<5;
* stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
* presenting an Excessive Daytime Sleepiness as indicated by an ESS\>or=12

Exclusion Criteria

* Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
* Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
* Patients with a severe depression indicated by (BDI\>= 16)or at suicidal risk (BDI item G\>0) or depression treated for less than 8 weeks
* Patients with a cognitive impairment

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No