Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

Theranexus

Status and phase: Completed; Phase 2

Conditions: Narcolepsy

Treatments: Drug: Active comparator: Modafinil + placebo; Drug: THN102 300/27; Drug: THN102 300/3

Study type: Interventional

Funder types: Industry

Identifiers

NCT02821715

2015-005035-41 (EudraCT Number)

THN102-201

Details and patient eligibility

About

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).

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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51 participants in 3 patient groups

Modafinil + placebo

Active Comparator group

Description:

3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks

Treatment:

Drug: Active comparator: Modafinil + placebo

THN102 300/3

Experimental group

Description:

3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks

Treatment:

Drug: THN102 300/3

THN102 300/27

Experimental group

Description:

3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks

Treatment:

Drug: THN102 300/27