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

NCT03182413 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-06-09

No results posted yet for this study

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.

Conditions

  • Sleep Deprivation

Interventions

DRUG

Placebo

DRUG

Modafinil

DRUG

THN102

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Theranexus

    lead INDUSTRY

Principal Investigators

  • Fabien Sauvet, MD, PhD · Institut de Recherche Biomedicale des Armees

  • Françoise Brunner-Ferber, PhD · Brunner Naga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-12-31
Completion
2016-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03182413 on ClinicalTrials.gov