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

Theranexus

Status and phase: Completed; Phase 1

Conditions: Sleep Deprivation

Treatments: Drug: Placebo; Drug: THN102; Drug: Modafinil

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03182413

THN102-102

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 5 patient groups, including a placebo group

PBO

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

MOD

Active Comparator group

Description:

Modafinil 100mg

Treatment:

Drug: Modafinil

THN102 100/1

Experimental group

Description:

modafinil 100 mg + 1 mg flecainide

Treatment:

Drug: THN102

THN102 100/3

Experimental group

Description:

modafinil 100 mg + 3 mg flecainide

Treatment:

Drug: THN102

THN102 100/9

Experimental group

Description:

modafinil 100 mg + 9 mg flecainide

Treatment:

Drug: THN102