Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)
This study has been completed.
Sponsor:
Bioprojet
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01067222
First received: February 9, 2010
Last updated: June 8, 2012
Last verified: June 2012
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Narcolepsy Excessive Daytime Sleepiness Cataplexy Sleep Disorders |
Drug: BF2.649 Drug: Modafinil Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
narcolepsy
MedlinePlus related topics:
Sleep Disorders
U.S. FDA Resources
Further study details as provided by Bioprojet:
Primary Outcome Measures:
- Epworth Sleepiness Scale (ESS) [ Time Frame: between baseline and at the end of 8 week DB phase ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). [ Time Frame: at inclusion and after 8-week treatment ] [ Designated as safety issue: No ]
| Enrollment: | 110 |
| Study Start Date: | May 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BF2.649 |
Drug: BF2.649
BF2.649 oral capsules at 10 or 20 or 40 mg per day
Other Name: Pitolisant
|
| Active Comparator: Modafinil |
Drug: Modafinil
Modafinil oral capsules at 100 or 200 or 400 mg per day
Other Name: Modiodal
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo oral capsules, 4 capsules per day
Other Name: placebo
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067222
Locations
| Switzerland | |
| Neurocenter (EOC) of Southern Switzerland | |
| Lugano, Switzerland, 6903 | |
Sponsors and Collaborators
Bioprojet
Investigators
| Principal Investigator: | Claudio Bassetti | Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland |
More Information
No publications provided
| Responsible Party: | Bioprojet |
| ClinicalTrials.gov Identifier: | NCT01067222 History of Changes |
| Other Study ID Numbers: | P07-03 / BF2.649, 2008-007866-46 |
| Study First Received: | February 9, 2010 |
| Last Updated: | June 8, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Switzerland: Swissmedic Hungary: National Institute of Pharmacy Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Bioprojet:
|
Narcolepsy Excessive daytime Sleepiness Cataplexy Sleep Disorders |
Sleep attacks Orphan Drug Pitolisant |
Additional relevant MeSH terms:
|
Cataplexy Narcolepsy Sleep Disorders Parasomnias Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias Nervous System Diseases Mental Disorders Neurologic Manifestations |
Signs and Symptoms Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013