Trial | NCT03182413  Report issue

Title

Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation
Therapeutic Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation in Healthy Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    modafinil ...

  • Study Participants

    20
Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h).

Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.
Study Started
Sep 30
2015
Primary Completion
Dec 31
2015
Study Completion
Mar 31
2016
Last Update
Jun 09
2017

Drug Placebo

Drug Modafinil

Drug THN102

PBO Placebo Comparator

Placebo

MOD Active Comparator

Modafinil 100mg

THN102 100/1 Experimental

modafinil 100 mg + 1 mg flecainide

THN102 100/3 Experimental

modafinil 100 mg + 3 mg flecainide

THN102 100/9 Experimental

modafinil 100 mg + 9 mg flecainide

Criteria 

Main inclusion Criteria:

Male subjects considered healthy and aged between 18 and 40 years
Subject with a body mass index (BMI) between 18 and 30 kg/m2
No Results Posted