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

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ClinicalTrials.gov Identifier: NCT03182413
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Collaborator:
Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Sleep Deprivation Drug: Placebo Drug: Modafinil Drug: THN102 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation in Healthy Subjects
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil

Arm Intervention/treatment
Placebo Comparator: PBO
Placebo
Drug: Placebo
Active Comparator: MOD
Modafinil 100mg
Drug: Modafinil
Experimental: THN102 100/1
modafinil 100 mg + 1 mg flecainide
Drug: THN102
Experimental: THN102 100/3
modafinil 100 mg + 3 mg flecainide
Drug: THN102
Experimental: THN102 100/9
modafinil 100 mg + 9 mg flecainide
Drug: THN102



Primary Outcome Measures :
  1. Sustained attention (PVT) [ Time Frame: 5 hours post treatment ]
    Mean speed at the 10 min Psychomotor vigilance test (PVT)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182413


Sponsors and Collaborators
Theranexus
Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
Investigators
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Principal Investigator: Fabien Sauvet, MD, PhD Institut de Recherche Biomedicale des Armees
Study Director: Françoise Brunner-Ferber, PhD Brunner Naga

Additional Information:
Publications:
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Responsible Party: Theranexus
ClinicalTrials.gov Identifier: NCT03182413     History of Changes
Other Study ID Numbers: THN102-102
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Theranexus:
modafinil
connexin
sleep deprivation
cognitive performance

Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action