Sleep DeprivationPhase 1NCT03182413

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

A Phase 1 study testing Modafinil and THN102 in people with Sleep Deprivation, run by Theranexus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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). Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Sleep Deprivation
What is being tested?: Modafinil and THN102
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: No sites listed yet
Study dates: Sep 2015to Mar 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Men only
Healthy volunteers accepted
Adult

Main inclusion Criteria:

Male subjects considered healthy and aged between 18 and 40 years
Subject with a body mass index (BMI) between 18 and 30 kg/m2

About this study

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

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: Sleep Deprivation
Being tested: Placebo, Modafinil, THN102
Keywords: modafinil, connexin, sleep deprivation, cognitive performance
Medical subject headings: Sleep Deprivation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
ModafinilDrug
THN102Drug

Study groups in NCT03182413
Study group	Role	What they receive
PBO	Placebo comparator	Placebo Receives: Drug: Placebo
MOD	Active comparator	Modafinil 100mg Receives: Drug: Modafinil
THN102 100/1	Experimental	modafinil 100 mg + 1 mg flecainide Receives: Drug: THN102
THN102 100/3	Experimental	modafinil 100 mg + 3 mg flecainide Receives: Drug: THN102
THN102 100/9	Experimental	modafinil 100 mg + 9 mg flecainide Receives: Drug: THN102

What is being measured

The primary outcome is the main question the study is designed to answer.

Sustained attention (PVT)
Mean speed at the 10 min Psychomotor vigilance test (PVT)
Measured: 5 hours post treatment

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Mar 2016

First posted9 Jun 2017
Study startSep 2015
Primary completionDec 2015
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Sleep DeprivationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03182413
Sponsor's protocol ID: THN102-102
Status last verified: Jun 2017
First submitted: 6 Jun 2017
Last updated: 9 Jun 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

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.
PubMed 27091533
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.
PubMed 31419329

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
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Neurobehavioral Changes Following Spaceflight Stressors
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The Function of Biphasic Sleep in Infants
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Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
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Sleep and Circadian Rhythm Intervention in ICU
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All Sleep Deprivation trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Therapeutic Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation in Healthy Subjects
ClinicalTrials.gov ID: NCT03182413
Acronym / sponsor ID: THN102-102
Conditions: Sleep Deprivation
Keywords: modafinil, connexin, sleep deprivation, cognitive performance
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: TheranexusIndustry (pharma, biotech, devices)
Collaborators: Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
Study start: Sep 2015
Primary completion: Dec 2015 (actual)
Study completion: Mar 2016 (actual)
First posted: 9 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
PBO	Placebo comparator	Drug: PlaceboPlacebo
MOD	Active comparator	Drug: ModafinilModafinil 100mg
THN102 100/1	Experimental	Drug: THN102modafinil 100 mg + 1 mg flecainide
THN102 100/3	Experimental	Drug: THN102modafinil 100 mg + 3 mg flecainide
THN102 100/9	Experimental	Drug: THN102modafinil 100 mg + 9 mg flecainide

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo	Drug	PBO
Modafinil	Drug	MOD
THN102	Drug	THN102 100/1, THN102 100/3, THN102 100/9

Primary outcome

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

4 secondary outcomes

Sustained attention (PVT) AUC
Time frame: AUC of PVT speed during TSD
Mental flexibility
Time frame: 16,5 hours post treatment
Mental inhibition
Time frame: 16,5 hours post treatment
Working memory
Time frame: 16,5 hours post treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
Background: PubMed 27091533Duchene 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.
Derived from this study: PubMed 31419329Sauvet 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 InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Sleep Deprivation

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Recruiting
The Function of Biphasic Sleep in Infants
Sleep Deprivation
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fabien Sauvet, MD, PhD principal investigator

Institut de Recherche Biomedicale des Armees

Françoise Brunner-Ferber, PhD study director

Brunner Naga

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Modafinil and THN102 in people with Sleep Deprivation, run by Theranexus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained attention (PVT) (time frame: 5 hours post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03182413, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.