Trials / Completed
CompletedNCT03182413
Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation
Therapeutic Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Theranexus · Industry
- Sex
- Male
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | |
| DRUG | Modafinil | |
| DRUG | THN102 |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2015-12-01
- Completion
- 2016-03-01
- First posted
- 2017-06-09
- Last updated
- 2017-06-09
Source: ClinicalTrials.gov record NCT03182413. Inclusion in this directory is not an endorsement.