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MELATONIN

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03514732Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep DisordersPHASE1 COMPLETED 40 — — Mar 17, 2017Jul 5, 2017Apr 25, 20221 Poland
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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 — 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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