Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-02-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Narcolepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Modafinil + placebo

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

Group Type ACTIVE_COMPARATOR

Active comparator: Modafinil + placebo

Intervention Type DRUG

THN102 300/3

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

Group Type EXPERIMENTAL

THN102 300/3

Intervention Type DRUG

THN102 300/27

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

Group Type EXPERIMENTAL

THN102 300/27

Intervention Type DRUG

Interventions

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Active comparator: Modafinil + placebo

Intervention Type DRUG

THN102 300/3

Intervention Type DRUG

THN102 300/27

Intervention Type DRUG

Other Intervention Names

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Modafinil 300 mg Flecainide Placebo Modafinil 300 mg Flecainide 3 mg Modafinil 300 mg Flecainide 27 mg

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No