Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)

NCT01399606 | Completed Phase 3 DMC

• 2 other identifiers: P09-10 / BF2.6492010-023804-28
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentric International Phase III,Long term open label study(12 months)assessing the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment of Excessive Daytime Sleepiness (EDS) in narcoleptic patients with or without cataplexy.

Conditions

Narcolepsy; Cataplexy

Keywords

Excessive Daytime Sleepiness (EDS); Narcolepsy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Event (TEAE)

  Number of Treatment Emergent Adverse Event (TEAE)

  12 months

Secondary Outcomes (1)

• efficacy on EDS as measured by ESS ( Epworth Sleepiness Scale)

  12 months

Study Arms (1)

BF2.649

EXPERIMENTAL

Drug: BF2.649

Interventions

BF2.649 DRUG

5,10,20,or 40 mg per day, in a once daily scheme

Also known as: Pitolisant

BF2.649

Eligibility Criteria

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

You may qualify if:

• Males or females, aged 18 years old and over.
• Patients with a diagnosis of narcolepsy according to the International Classification of Sleep Disorders (ICSD-2) criteria.
• Patients should have complained of EDS with an ESS score at least 12 (historical assessment).
• Patients having previously participated in and completed a Bioprojet narcolepsy study assessing BF2.649 efficacy (P05-03, P06-06, P07-03 HARMONY I or P07-07 HARMONY II, P09-15 HARMONY I bis) or narcoleptic patients complaining with EDS which in the opinion of the investigator would not be able to participate in a double blind study against placebo but who could benefit from testing a new therapy such as the BF2.649 in an open label study.
• or patient receiving BF2.649(Pitolisant) under condition of"ATU nominative" according to the French law (called named temporary authorization of use approved by the Afssaps) for Excessive Daytime Sleepiness associated with narcolepsy.

You may not qualify if:

• Patients who have discontinued study treatment during the previous studies due to adverse events related to BF2.649.
• Patients with an untreated sleep apnoea syndrome or who have any other cause of daytime sleepiness
• Patients working in an occupation requiring variable shift work or routine night shifts.
• Psychiatric and neurological disorders, other than narcolepsy/cataplexy, or other problem that in the investigator's opinion would preclude the patient's participation and completion of this trial or comprise reliable representation of subjective symptoms.
• Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in DSM-IV.
• Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study participation.
• Known history of long QTc syndrome, syncope or arrhythmia or any significant serious abnormality of the ECG (e.g. recent myocardial infarction), or QTc interval strictly higher than 450 ms (electrocardiogram Bazett's corrected QT interval
• Severe Hepatic Impairment or with Severe Renal Impairment, or with any other significant abnormality in the physical examination or clinical laboratory results.
• Known hypersensitivity to the tested treatment including active substance and excipients.
• Participation in an other study - in the 30 days prior to the entry in this study

Sponsors & Collaborators

• Bioprojet: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Narcolepsy; Cataplexy; Disorders of Excessive Somnolence

Interventions

pitolisant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kati Gutierrez, PharmD

  Bioprojet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: July 22, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: September 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

FR (1)