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

Sleep Deprivation Clinical Trial

Official title:

Therapeutic Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182413
• Other study ID #: THN102-102
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2017
• Last updated: June 8, 2017
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2017
• Source: Theranexus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Drug:
• Placebo

• Modafinil

• THN102

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Theranexus	Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France

References & Publications (1)

Duchêne A, Perier M, Zhao Y, Liu X, Thomasson J, Chauveau F, Piérard C, Lagarde D, Picoli C, Jeanson T, Mouthon F, Dauvilliers Y, Giaume C, Lin JS, Charvériat M. Impact of Astroglial Connexins on Modafinil Pharmacological Properties. Sleep. 2016 Jun 1;39(6):1283-92. doi: 10.5665/sleep.5854. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained attention (PVT)	Mean speed at the 10 min Psychomotor vigilance test (PVT)	5 hours post treatment
Secondary	Sustained attention (PVT) AUC	AUC of speed values at the 10 min Psychomotor vigilance test (PVT)	AUC of PVT speed during TSD
Secondary	Mental flexibility	Wisconsin card sorting test	16,5 hours post treatment
Secondary	Mental inhibition	GO-noGO	16,5 hours post treatment
Secondary	Working memory	2-Back	16,5 hours post treatment

External Links

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