Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy (Harmony2)
This study has been completed.
Sponsor:
Bioprojet
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01067235
First received: February 9, 2010
Last updated: February 8, 2013
Last verified: June 2012
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Purpose
The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy
| Condition | Intervention | Phase |
|---|---|---|
|
Narcolepsy Cataplexy Excessive Daytime Sleepiness |
Drug: BF2.649 Drug: BF2.649 add on Modafinil |
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, Parallel-group, Multi-center Trial Assessing the Effects of Escalating Doses of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With 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:
- Cataplexy attacks reported on sleep diary [ Time Frame: every days from screening visit (day-14) to final visit (day 56) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Sleep Diary: number and duration of diurnal sleep and sleepiness episodes, [ Time Frame: every days from screening visit (day-14) to final visit (day 56) ] [ Designated as safety issue: Yes ]
- 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 ]
- Epworth Sleepiness Scale (ESS) [ Time Frame: at each visit ] [ Designated as safety issue: No ]
| Enrollment: | 14 |
| Study Start Date: | October 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BF2.649 + Modafinil placebo |
Drug: BF2.649
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks
Other Name: Pitolisant
|
| Experimental: BF2.649 + Modafinil |
Drug: BF2.649 add on Modafinil
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks
Other Names:
|
Detailed Description:
BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.
The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- "De novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy
- patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months
- partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS >or= 14 at the end of the baseline period
Exclusion Criteria:
- Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
- Current or recent history of a substance abuse or dependence disorder including alcohol abuse
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067235
Locations
| Switzerland | |
| Neurocenter (EOC) of Southern Switzerland | |
| Lugano, Switzerland, 6903 | |
Sponsors and Collaborators
Bioprojet
Investigators
| Principal Investigator: | Claudio Bassetti | Neurocenter of Southern Switzerland,Lugano |
More Information
No publications provided
| Responsible Party: | Bioprojet |
| ClinicalTrials.gov Identifier: | NCT01067235 History of Changes |
| Other Study ID Numbers: | P07-07 / BF2.649, 2008-007845-29 |
| Study First Received: | February 9, 2010 |
| Last Updated: | February 8, 2013 |
| 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:
|
Narcolespy Cataplexy Excesssive daytime Sleepiness Sleep Disorders |
Sleep attacks Orphan Drug Pitolisant |
Additional relevant MeSH terms:
|
Cataplexy Narcolepsy Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders |
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