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| Name | Class |
|---|---|
| Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBO | Placebo Comparator | Placebo |
|
| MOD | Active Comparator | Modafinil 100mg |
|
| THN102 100/1 | Experimental | modafinil 100 mg + 1 mg flecainide |
|
| THN102 100/3 | Experimental | modafinil 100 mg + 3 mg flecainide |
|
| THN102 100/9 | Experimental | modafinil 100 mg + 9 mg flecainide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Modafinil |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained attention (PVT) | Mean speed at the 10 min Psychomotor vigilance test (PVT) | 5 hours post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained attention (PVT) AUC | AUC of speed values at the 10 min Psychomotor vigilance test (PVT) | AUC of PVT speed during TSD |
| Mental flexibility | Wisconsin card sorting test |
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Main inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabien Sauvet, MD, PhD | Institut de Recherche Biomedicale des Armees | Principal Investigator |
| Françoise Brunner-Ferber, PhD | Brunner Naga | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27091533 | Background | 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. | |
| 31419329 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| THN102 | Drug |
|
| 16,5 hours post treatment |
| Mental inhibition | GO-noGO | 16,5 hours post treatment |
| Working memory | 2-Back | 16,5 hours post treatment |
| 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |