Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-12-31

Brief Summary

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The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)

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Detailed Description

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BF 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (EDS) evaluated by Epworth Sleepiness Scale (ESS), according the results of two previous clinical studies.

The objective of this study is to determine the efficacy and safety of BF2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and Modafinil as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.

60 patients with narcolepsy with or without cataplexy will be included.

Conditions

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Narcolepsy Excessive Daytime Sleepiness Cataplexy Sleep Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BF2.649

Group Type EXPERIMENTAL

BF2.649

Intervention Type DRUG

BF2.649 oral capsules at 10 or 20 or 40 mg per day

Modafinil

Group Type ACTIVE_COMPARATOR

Modafinil

Intervention Type DRUG

Modafinil oral capsules at 100 or 200 or 400 mg per day

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral capsules, 4 capsules per day

Interventions

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BF2.649

BF2.649 oral capsules at 10 or 20 or 40 mg per day

Intervention Type DRUG

Modafinil

Modafinil oral capsules at 100 or 200 or 400 mg per day

Intervention Type DRUG

Placebo

Placebo oral capsules, 4 capsules per day

Intervention Type DRUG

Other Intervention Names

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Pitolisant Modiodal

Eligibility Criteria

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Inclusion Criteria

* diagnosis of narcolepsy with or without cataplexy
* patients need to free of or discontinue psychostimulant medications for at least 14 days,
* patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses
* patients must have adequate support to comply with the entire study requirements

Exclusion Criteria

* Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness
* Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
* Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
* Current or recent history of a substance abuse or dependence disorder including alcohol abuse

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No