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Completed

NCT Number: NCT03182413

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

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.

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Key information

Conditions

Sleep Deprivation Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Modafinil

Drug

THN102

Drug

Primary outcomes

  1. Sustained attention (PVT)

    Time frame: 5 hours post treatment

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

Secondary outcomes

  1. Sustained attention (PVT) AUC

    Time frame: AUC of PVT speed during TSD

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

  2. Mental flexibility

    Time frame: 16,5 hours post treatment

    Wisconsin card sorting test

  3. Mental inhibition

    Time frame: 16,5 hours post treatment

    GO-noGO

  4. Working memory

    Time frame: 16,5 hours post treatment

    2-Back

Sponsors and collaborators

Lead sponsor

Theranexus

Industry

Collaborators

  • Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 9, 2017
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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