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Completed

NCT Number: NCT01067222

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

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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Key information

Conditions

Narcolepsy Cataplexy Disorders of Excessive Somnolence Dyssomnias Excessive Daytime Sleepiness Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neurocenter (EOC) of Southern Switzerland

Lugano, 6903, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BF2.649

Drug

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

Other names: Pitolisant

Modafinil

Drug

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

Other names: Modiodal

Placebo

Drug

Placebo oral capsules, 4 capsules per day

Primary outcomes

  1. Epworth Sleepiness Scale (ESS)

    Time frame: between baseline and at the end of 8 week DB phase

Secondary outcomes

  1. Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks

    Time frame: 14 days before randomization and 7 days before each visit

  2. Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).

    Time frame: at inclusion and after 8-week treatment

Sponsors and collaborators

Lead sponsor

Bioprojet

Other

Registry information

Official study title

Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy

Acronym: Harmony1

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 11, 2010
Registry last updated
Jun 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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