Clinical trial NCT01399606 (phase 3, status: completed)
Conditions: narcolepsy, cataplexy
ICD codes: G47.411, G47.419, G47.421, G47.429
Drugs: bf2.649
SMILES: ClC1=CC=C(CCCOCCCN2CCCCC2)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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