Clinical trial NCT02821715: Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
Official title: Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Narcolepsy
Lead sponsor: Theranexus
Sponsor class: INDUSTRY
First posted: 2016-07-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).

Detailed description: The 3 double blind periods (2-week) follow a stabilisation period for modafinil at 300 mg/day (open, 2-week) and are followed by a one-week washout period with the same modafinil dose.

Eligibility criteria: Main inclusion Criteria:

* Patients with a diagnosis of narcolepsy type 1 (i.e. with cataplexy) or type 2 (without cataplexy) according to the International Classification of Sleep Disorders (ICSD-3) criteria.
* Body mass index \>18 kg/m2 and \<35 kg/m2.
* Patients treated with modafinil at stable dosage for at least 2 months and still complaining of excessive daily somnolence (EDS) despite the treatment
* Epworth Sleepiness Scale (ESS) score should be ≥ 14/24 during the baseline period.

Main exclusion Criteria:

* Patients with an untreated sleep apnea syndrome (respiratory disorder index \> 30/h) or who have any other cause of daytime sleepiness as assessed on patient history.
* Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as Parkinson's disease, Alzheimer's disease, Huntington's Chorea, multiple sclerosis, moderate or severe psychosis or dementia, bipolar illness, epilepsy, severe clinical anxiety or depression, Beck Depression Inventory ≥ 21 or with suicidal risk (if item \> 0), 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.
* Contraindication to flecainide

Primary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 14 days after the beginning of treatment period
Secondary outcomes:
measure: 14-item Fatigue Scale
timeFrame: 14 days after the beginning of treatment period
measure: Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)
timeFrame: 14 days after the beginning of the screening
measure: Patient Global Impression of Change (PGI-C)
timeFrame: 14 days after the beginning of treatment period
measure: Clinical Global Impression of Change (CGI-C) Global Impression
timeFrame: 14 days after the end of treatment period I
measure: Beck Depression Inventory (BDI)
timeFrame: 14 days
measure: Patient Global Impression for Severity (PGI-S) Global Score
timeFrame: 14 days
measure: Clinical Global Impression of Change (CGI-C) Sleepiness
timeFrame: 14 days after the end of treatment period I
measure: Clinical Global Impression of Change (CGI-C) Cataplexy
timeFrame: 14 days after the end of treatment period I
measure: Clinical Global Impression for Severity (CGI-S) Global Score
timeFrame: 14 days after the end of treatment period I
measure: Clinical Global Impression for Severity (CGI-S) Sleepiness
timeFrame: 14 days after the end of treatment period I
measure: Clinical Global Impression for Severity (CGI-S) Cataplexy
timeFrame: 14 days after the end of treatment period I
measure: EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)
timeFrame: 14 days
Other outcomes:
Locations:
city: Erpent
country: Belgium
facility: RespiSom
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Garches
country: France
facility: Hôpital Raymond Poincaré
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lille
country: France
facility: CHRU Lilles
city: Montpellier
country: France
facility: University Hospital
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière
Study officials:
affiliation: CHRU Montpellier, France
name: Yves Dauvilliers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: