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MELATONIN

Phase 1

Sleep Disorder (Healthy Volunteers) | Small molecule | Other |Sanofi|Last Updated: Apr 25, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

MELATONIN · 1 trial · 1 indication

Phase 1 1
NCT03514732Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep DisordersSleep Disorder (Healthy Volunteers)
COMPLETED40 Analytics
PHASE1COMPLETED
Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
Sleep Disorder (Healthy Volunteers)Unlock trial analytics

Study Endpoints

Primary Endpoints

Comparison of the sleep quality
From baseline to Day 21

Difference in the average score of sleep quality

Secondary Endpoints

Comparison of the average scores of sleep quality
From baseline to Day 28
Comparison of time for getting asleep
From baseline to Day 28
Comparison of sleep time
From baseline to Day 28
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Novanuit® Triple ActionEXPERIMENTAL2 capsules of Novanuit® Triple Action once daily for 2 weeks, 30 minutes to 1 hour before bedtime.

Interventions

NameTypeDescription
MELATONIN (MELATL07959)DRUGPharmaceutical form:Capsule Route of administration: Oral
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria : * Healthy men or women volunteers, aged from 20 to 75 years included at the moment of the inclusion visit. * Subject with Body Mass Index (BMI) between 18.5 and 29.9 kg/m² (limits included). * Good general health (based on subject interview about his/her medical history and on ...

Countries:Poland
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Frequently asked questions about MELATONIN

What is MELATONIN used for?

MELATONIN is being studied for use in sleep disorders in healthy volunteers. It is an investigational small molecule in Phase 1 clinical development, evaluated for its ability to improve the quality of sleep in individuals with sleep disorders.

Who makes MELATONIN?

MELATONIN is being developed by Sanofi, a company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical development for sleep disorders.

What phase is MELATONIN in?

MELATONIN is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is MELATONIN in?

MELATONIN has one completed clinical trial, identified as NCT03514732, titled 'Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders.' The trial was conducted in Poland with 40 participants.

Is MELATONIN the same as NOVANUIT?

MELATONIN is being studied under the brand name NOVANUIT® Triple Action in the clinical trial NCT03514732. The trial evaluates the quality of sleep improvements with this product in healthy volunteers with sleep disorders.