Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation
NCT ID: NCT03182413
Last Updated: 2017-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2015-09-30
2016-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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PBO
Placebo
Placebo
MOD
Modafinil 100mg
Modafinil
THN102 100/1
modafinil 100 mg + 1 mg flecainide
THN102
THN102 100/3
modafinil 100 mg + 3 mg flecainide
THN102
THN102 100/9
modafinil 100 mg + 9 mg flecainide
THN102
Interventions
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Placebo
Modafinil
THN102
Eligibility Criteria
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Inclusion Criteria
2. Subject with a body mass index (BMI) between 18 and 30 kg/m2
18 Years
40 Years
MALE
Yes
Sponsors
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Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
UNKNOWN
Theranexus
INDUSTRY
Responsible Party
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Principal Investigators
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Fabien Sauvet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherche Biomedicale des Armees
Françoise Brunner-Ferber, PhD
Role: STUDY_DIRECTOR
Brunner Naga
References
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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.
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.
Related Links
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Related Info
Other Identifiers
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THN102-102
Identifier Type: -
Identifier Source: org_study_id
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