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

June 8, 2017 updated by: Theranexus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PBO
Placebo
Drug: Placebo
Active Comparator: MOD
Modafinil 100mg
Drug: Modafinil
Experimental: THN102 100/1
modafinil 100 mg + 1 mg flecainide
Drug: THN102
Experimental: THN102 100/3
modafinil 100 mg + 3 mg flecainide
Drug: THN102
Experimental: THN102 100/9
modafinil 100 mg + 9 mg flecainide
Drug: THN102

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained attention (PVT)
Time Frame: 5 hours post treatment
Mean speed at the 10 min Psychomotor vigilance test (PVT)
5 hours post treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theranexus

Collaborators

Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France

Investigators

  • Study Director: Françoise Brunner-Ferber, PhD, Brunner Naga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THN102-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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