Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation
- Registration Number
- NCT03182413
- Lead Sponsor
- Theranexus
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description THN102 100/9 THN102 modafinil 100 mg + 9 mg flecainide THN102 100/3 THN102 modafinil 100 mg + 3 mg flecainide PBO Placebo Placebo THN102 100/1 THN102 modafinil 100 mg + 1 mg flecainide MOD Modafinil Modafinil 100mg
- Primary Outcome Measures
Name Time Method Sustained attention (PVT) 5 hours post treatment Mean speed at the 10 min Psychomotor vigilance test (PVT)
- Secondary Outcome Measures
Name Time Method Working memory 16,5 hours post treatment 2-Back
Sustained attention (PVT) AUC AUC of PVT speed during TSD AUC of speed values at the 10 min Psychomotor vigilance test (PVT)
Mental flexibility 16,5 hours post treatment Wisconsin card sorting test
Mental inhibition 16,5 hours post treatment GO-noGO