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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01399606
• Date of registration: 21/06/2011
• Prospective Registration: No
• Primary sponsor: Bioprojet
• Public title: Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant) HARMONYIII
• Scientific title: An Open-label Naturalistic Pragmatic Study to Assess the Long Term Safety of BF2.649 (Pitolisant) in the Treatment of Excessive Daytime Sleepiness (EDS) in Narcolepsy (12 Months Follow-up, Followed by a Prolonged Follow up)
• Date of first enrolment: May 2011
• Target sample size: 102
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01399606
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France, Hungary, Italy

Contacts

• Name: Kati Gutierrez, PharmD
• Affiliation: Bioprojet

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cataplexy

Narcolepsy

Intervention(s)

Drug: BF2.649

Primary Outcome(s)

Incidence of Treatment Emergent Adverse Event (TEAE) [Time Frame: 12 months]

Secondary Outcome(s)

efficacy on EDS as measured by ESS ( Epworth Sleepiness Scale) [Time Frame: 12 months]

Secondary ID(s)

2010-023804-28

P09-10 / BF2.649

Source(s) of Monetary Support

Please refer to primary and secondary sponsors