Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy

NCT01067235 | Completed Phase 3

• 2 other identifiers: P07-07 / BF2.6492008-007845-29
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Narcolepsy; Cataplexy; Excessive Daytime Sleepiness

Keywords

Narcolespy; Cataplexy; Excesssive daytime Sleepiness; Sleep Disorders; Sleep attacks; Orphan Drug; Pitolisant

Outcome Measures

Primary Outcomes (1)

• Cataplexy attacks reported on sleep diary

  every days from screening visit (day-14) to final visit (day 56)

Secondary Outcomes (3)

• Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,

  every days from screening visit (day-14) to final visit (day 56)

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

  at inclusion and after 8-week treatment

• Epworth Sleepiness Scale (ESS)

  at each visit

Study Arms (2)

BF2.649 + Modafinil placebo

EXPERIMENTAL

Drug: BF2.649

BF2.649 + Modafinil

EXPERIMENTAL

Drug: BF2.649 add on Modafinil

Interventions

BF2.649 DRUG

BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks

Also known as: Pitolisant

BF2.649 + Modafinil placebo

BF2.649 add on Modafinil DRUG

BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks

Also known as: Pitolisant, Modiodal

BF2.649 + Modafinil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• "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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioprojet: lead

Study Sites (1)

Neurocenter (EOC) of Southern Switzerland

Lugano, 6903, Switzerland

Location

MeSH Terms

Conditions

Narcolepsy; Cataplexy; Disorders of Excessive Somnolence; Sleep Wake Disorders

Interventions

pitolisant; Modafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Claudio Bassetti

  Neurocenter of Southern Switzerland,Lugano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 11, 2010
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 11, 2013

Record last verified: 2012-06

Locations

CH (1)