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

Primary Purpose

Sleep Deprivation

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
Modafinil
THN102
Sponsored by
Theranexus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Deprivation focused on measuring modafinil, connexin, sleep deprivation, cognitive performance

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Placebo Comparator

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    PBO

    MOD

    THN102 100/1

    THN102 100/3

    THN102 100/9

    Arm Description

    Placebo

    Modafinil 100mg

    modafinil 100 mg + 1 mg flecainide

    modafinil 100 mg + 3 mg flecainide

    modafinil 100 mg + 9 mg flecainide

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Sustained attention (PVT) AUC
    AUC of speed values at the 10 min Psychomotor vigilance test (PVT)
    Mental flexibility
    Wisconsin card sorting test
    Mental inhibition
    GO-noGO
    Working memory
    2-Back

    Full Information

    First Posted
    June 6, 2017
    Last Updated
    June 8, 2017
    Sponsor
    Theranexus
    Collaborators
    Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03182413
    Brief Title
    Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation
    Official Title
    Therapeutic Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Theranexus
    Collaborators
    Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Deprivation
    Keywords
    modafinil, connexin, sleep deprivation, cognitive performance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PBO
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    MOD
    Arm Type
    Active Comparator
    Arm Description
    Modafinil 100mg
    Arm Title
    THN102 100/1
    Arm Type
    Experimental
    Arm Description
    modafinil 100 mg + 1 mg flecainide
    Arm Title
    THN102 100/3
    Arm Type
    Experimental
    Arm Description
    modafinil 100 mg + 3 mg flecainide
    Arm Title
    THN102 100/9
    Arm Type
    Experimental
    Arm Description
    modafinil 100 mg + 9 mg flecainide
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Modafinil
    Intervention Type
    Drug
    Intervention Name(s)
    THN102
    Primary Outcome Measure Information:
    Title
    Sustained attention (PVT)
    Description
    Mean speed at the 10 min Psychomotor vigilance test (PVT)
    Time Frame
    5 hours post treatment
    Secondary Outcome Measure Information:
    Title
    Sustained attention (PVT) AUC
    Description
    AUC of speed values at the 10 min Psychomotor vigilance test (PVT)
    Time Frame
    AUC of PVT speed during TSD
    Title
    Mental flexibility
    Description
    Wisconsin card sorting test
    Time Frame
    16,5 hours post treatment
    Title
    Mental inhibition
    Description
    GO-noGO
    Time Frame
    16,5 hours post treatment
    Title
    Working memory
    Description
    2-Back
    Time Frame
    16,5 hours post treatment

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fabien Sauvet, MD, PhD
    Organizational Affiliation
    Institut de Recherche Biomedicale des Armees
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Françoise Brunner-Ferber, PhD
    Organizational Affiliation
    Brunner Naga
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27091533
    Citation
    Duchene A, Perier M, Zhao Y, Liu X, Thomasson J, Chauveau F, Pierard C, Lagarde D, Picoli C, Jeanson T, Mouthon F, Dauvilliers Y, Giaume C, Lin JS, Charveriat M. Impact of Astroglial Connexins on Modafinil Pharmacological Properties. Sleep. 2016 Jun 1;39(6):1283-92. doi: 10.5665/sleep.5854.
    Results Reference
    background
    PubMed Identifier
    31419329
    Citation
    Sauvet F, Erblang M, Gomez-Merino D, Rabat A, Guillard M, Dubourdieu D, Lefloch H, Drogou C, Van Beers P, Bougard C, Bourrrilhon C, Arnal P, Rein W, Mouthon F, Brunner-Ferber F, Leger D, Dauvilliers Y, Chennaoui M, Charveriat M. Efficacy of THN102 (a combination of modafinil and flecainide) on vigilance and cognition during 40-hour total sleep deprivation in healthy subjects: Glial connexins as a therapeutic target. Br J Clin Pharmacol. 2019 Nov;85(11):2623-2633. doi: 10.1111/bcp.14098. Epub 2019 Sep 15.
    Results Reference
    derived
    Links:
    URL
    http://www.theranexus.com
    Description
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    Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation

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