Trial record 6 of 42 for:    "narcolepsy"

Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01067222
First received: February 9, 2010
Last updated: June 8, 2012
Last verified: June 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Narcolepsy
Cataplexy
Sleep Disorders
Parasomnias
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014