Status:
COMPLETED
Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)
Lead Sponsor:
Bioprojet
Conditions:
Narcolepsy
Cataplexy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
In narcoleptic patients, results obtained in the previous studies showed that BF2.649 reduced significantly the diurnal somnolence compared to placebo confirming its wakening effect against EDS and de...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01399606
Start Date
May 1 2011
End Date
September 1 2016
Last Update
January 31 2017
Active Locations (1)
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1
CHU Montpellier
Montpellier, France, 34000