Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation

Theranexus20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sleep Deprivation

Interventions

PlaceboDRUG

ModafinilDRUG

THN102DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Main inclusion Criteria: 1. Male subjects considered healthy and aged between 18 and 40 years 2. Subject with a body mass index (BMI) between 18 and 30 kg/m2

Outcomes

Primary Outcomes

Sustained attention (PVT)

Mean speed at the 10 min Psychomotor vigilance test (PVT)

Time frame: 5 hours post treatment

Secondary Outcomes

Sustained attention (PVT) AUC

AUC of speed values at the 10 min Psychomotor vigilance test (PVT)

Time frame: AUC of PVT speed during TSD

Mental flexibility

Wisconsin card sorting test

Time frame: 16,5 hours post treatment

Mental inhibition

GO-noGO

Time frame: 16,5 hours post treatment

Working memory

2-Back

Time frame: 16,5 hours post treatment

Data from ClinicalTrials.gov

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