NCT03182413

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

June 6, 2017

Last Update Submit

June 8, 2017

Conditions

Sleep Deprivation

Keywords

modafinilconnexinsleep deprivationcognitive performance

Outcome Measures

Primary Outcomes (1)

  • Sustained attention (PVT)

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

    5 hours post treatment

Secondary Outcomes (4)

  • Sustained attention (PVT) AUC

    AUC of PVT speed during TSD

  • Mental flexibility

    16,5 hours post treatment

  • Mental inhibition

    16,5 hours post treatment

  • Working memory

    16,5 hours post treatment

Study Arms (5)

PBO

PLACEBO COMPARATOR

Placebo

Drug: Placebo

MOD

ACTIVE COMPARATOR

Modafinil 100mg

Drug: Modafinil

THN102 100/1

EXPERIMENTAL

modafinil 100 mg + 1 mg flecainide

Drug: THN102

THN102 100/3

EXPERIMENTAL

modafinil 100 mg + 3 mg flecainide

Drug: THN102

THN102 100/9

EXPERIMENTAL

modafinil 100 mg + 9 mg flecainide

Drug: THN102

Interventions

PlaceboDRUG
PBO
ModafinilDRUG
MOD
THN102DRUG
THN102 100/1THN102 100/3THN102 100/9

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male subjects considered healthy and aged between 18 and 40 years
  • Subject with a body mass index (BMI) between 18 and 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27091533BACKGROUND

  • 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.

    PMID: 31419329DERIVED

Related Links

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Modafinil

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Fabien Sauvet, MD, PhD

    Institut de Recherche Biomedicale des Armees

    PRINCIPAL INVESTIGATOR

  • Françoise Brunner-Ferber, PhD

    Brunner Naga

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 9, 2017

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

June 9, 2017

Record last verified: 2017-06