Clinical trials: Melatonin
Sleep
A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity
This study will evaluate the efficacy of Asutra's 'Dream the night away' nighttime lotion with melatonin and magnesium on sleep health in terms of quantity, quality, ease of falling asleep or falling back asleep after waking in…
- Trial name
- NCT06146712
- Testing
- Asutra's 'Dream the night away' nighttime lotion
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Asutra
Postural Instability
Investigation of Melatonin and Zolpidem Effect on Postural Instability in Healthy Adult Subjects
This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on night time awakening body sway of melatonin and zolpidem in healthy adult subjects aged of 55 to 64 years.
- Trial name
- NCT01280734
- Testing
- Circadin (R) 2 mg, Stilnox (R) 10 mg
- Where
- France
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Neurim Pharmaceuticals Ltd.
Melatonin Bioavailability
Kinetic of Compounds of a Melatonin-based Formulation in Healthy Subjects
This study is conducted to clinically document the melatonin and zinc bioavailability of a dietary supplement containing delayed release melatonin, zinc and lemon balm
- Trial name
- NCT05419466
- Testing
- dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm
- Where
- France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Larena SAS
Alzheimer Disease, Agitation,Psychomotor
Clinical Trial on Agitation in Alzheimer's Dementia
The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from…
- Conditions
- Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden, NPS
- Trial name
- CALMA (NCT05543681)
- Testing
- IGC-AD1-Active
- Where
- 28 sites in United States, Canada and 1 more
- Volunteers
- 164 people
- Sponsor
- IGC Pharma, LLC
Sleep Disorders, Autism Spectrum Disorder
Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders
The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.
- Trial name
- NPC-15-5 (NCT02757066)
- Testing
- NPC-15 Granules Lower Dose, NPC-15 Granules Higher Dose
- Volunteers
- 196 people
- Sponsor
- Nobelpharma
Healthy
A Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults
A study comparing the pharmacokinetics of prolonged-release melatonin versus standard, immediate-release melatonin. Multiple blood draws over a 10-hour period will be analysed to determine the area under the curve, time to peak…
- Trial name
- NCT04067791
- Testing
- Prolonged-Release Melatonin, Immediate-Release Melatonin
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pharmavite LLC
Primary Insomnia
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.
- Trial name
- NCT00397189
- Testing
- Circadin
- Where
- United Kingdom
- Volunteers
- 930 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Primary Insomnia
Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs
The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.
- Trial name
- Neu I (NCT00816673)
- Testing
- Circadin
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Female Infertility
Myo-inositol and Vitamin D3 During IVF
Administration of a multicomponent dietary supplement (myo-inositol, vitamin D3, folic acid and melatonin) to women undergoing IVF procedures.
- Trial name
- NCT04019899
- Testing
- control group, study group
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- Lo.Li.Pharma s.r.l
Smith Magenis Syndrome
Observational Study to Investigate the Melatonin and Cortisol Circadian Rhythms of Individuals With Smith-Magenis Syndrome (SMS)
The purpose of this study is to characterize the circadian rhythm disruption experienced by patients as determined by plasma melatonin, cortisol, and other circadian analytes
- Trial name
- NCT02180451
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Vanda Pharmaceuticals
Sleep Problems
Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances
There is increasing evidence that chronic sleep disorders in children with autism spectrum disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with disturbed melatonin secretion and melatonin…
- Trial name
- NCT01903681
- Testing
- Circadin 2 mg, Circadin 10 mg
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Sleep Disorders
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy…
- Trial name
- NCT01906866
- Testing
- Circadin 2/5/10 mg
- Where
- 28 sites in United States, Finland and 3 more
- Volunteers
- 125 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Diabetes Mellitus, Type 2, Insomnia
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on glucose lipid metabolism and sleep is studied…
- Trial name
- NCT00869128
- Testing
- Circadin
- Volunteers
- 36 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Sleep
Somato® (Phytomelatonin) Versus Synthetic Melatonin and Placebo on Sleep Quality
This study examines the effects of a plant-based phytomelatonin supplement compared to synthetic melatonin and placebo in adults with suboptimal sleep quality.
- Trial name
- NCT07669766
- Testing
- Plant-based melatonin, Melatonin
- Where
- United States
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- Nutraland USA, Inc.
Sleep Disorders, Neurodevelopmental Disorder
Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders
The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.
- Trial name
- NPC-15-6 (NCT02757079)
- Testing
- NPC-15
- Volunteers
- 99 people
- Sponsor
- Nobelpharma
Melatonin Bioavailability
Kinetic of Melatonin Subsequent to the Consumption of Melatonin-rich Food Supplements
This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays.
- Trial name
- NCT04574141
- Testing
- a prolonged release tablet and a spray containing melatonin
- Where
- France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- PiLeJe
COVID-19, SARS-CoV 2
Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19
There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects.
- Conditions
- COVID-19, SARS-CoV 2, Coronavirus Infection
- Trial name
- MELCOVID (NCT04568863)
- Testing
- Melatonin intravenous
- Where
- Spain
- Volunteers
- 18 people
- Sponsor
- Pharmamel S.L.
Breast Cancer, Lung Cancer
Effects of Somnage® in the Management on Sleep and Mood in Cancer Patients
The aim of this placebo-controlled randomized study is to evaluate the effects of Melatonin 1mg/Zn 30% VNR/Mg 100% VNR (food supplement) in the management on sleep quality and mood alteration in cancer patients
- Conditions
- Breast Cancer, Lung Cancer, Colon Cancer
- Trial name
- NCT02883790
- Testing
- Somnage
- Where
- 5 sites in Italy
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Helsinn Healthcare SA
Parkinson's Disease
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease
This clinical study is a double-blind, randomized, placebo-controlled trial to investigate the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients, symptoms which have a significant impact on…
- Trial name
- NCT02768077
- Testing
- Melatonin(Circadin®)
- Volunteers
- 100 people
- Sponsor
- Kuhnil Pharmaceutical Co., Ltd.
Sleep Disturbance, Sleep Quality
A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of Various Cannabinoids on Sleep Quality
This double-blind, randomized, placebo-controlled study will assess the safety and effects of different combinations of CBN, CBG, and THC, with and without CBD and melatonin, for enhancing sleep quality, other factors related to…
- Trial name
- NCT07769164
- Testing
- 2 mg THC + 2 mg CBN + 2 mg CBG + 10 mg CBD + 1 mg Melatonin, 10 mg THC + 5 mg CBN + 5 mg CBG + 20 mg CBD, 10 mg THC + 20 mg CBN + 5 mg CBG
- Where
- United States
- Volunteers
- 332 people, healthy volunteers welcome
- Sponsor
- Cannabis Science Innovations, LLC