Clinical trials: Melatonin
Primary Insomnia
Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to receive Neu-P11 20 mg, Neu-P11 50 mg or placebo…
- Trial name
- NCT01489969
- Testing
- Neu-P11
- Where
- 9 sites in United States
- Volunteers
- 137 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
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.
Sleep Quality, Sleep Health
Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
The primary objective of this study is to evaluate the effects of a proprietary oral supplement on the sleep health and quality of people with sleep problems. It is a double-blinded placebo-controlled crossover clinical study.
- Trial name
- NCT05368909
- Testing
- Sleep Supplement
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- 4Life Research, LLC
Non-24 Hour Sleep-Wake Disorder, Blindness
Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects
The aim of this placebo-controlled randomized study was to evaluate the efficacy of Circadin™ 2 mg in improving total night sleep duration and stabilizing the circadian clock phase in totally blind subjects with non-24 hour…
- Trial name
- NCT00972075
- Testing
- melatonin (Circadin)
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Oral Mucositis
Melatonin Oral Gel for Oral Mucositis in Patients With Head and Neck Cancer Undergoing Chemoradiation
The main purpose of this study is to assess the efficacy of melatonin oral gel compared to placebo in the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing concurrent chemoradiation.
- Trial name
- MUCOMEL (NCT02630004)
- Testing
- Melatonin oral gel 3%
- Where
- 11 sites in Spain
- Volunteers
- 84 people
- Sponsor
- Spherium Biomed
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.
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
Major Depressive Disorder
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked treatment of tasimelteon or placebo in male and female subjects with Major Depressive Disorder.
- Trial name
- MAGELLAN (NCT01428661)
- Testing
- tasimelteon
- Where
- 40 sites in United States
- Volunteers
- 507 people
- Sponsor
- Vanda Pharmaceuticals
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.
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
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
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.
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
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.
Endoscopic Sinus Surgery
The Effect of Dexmedetomidine, Melatonin and Pregabalin
Various drugs have been used for the purpose: nitroglycerine, sodium nitroprusside, propofol, beta blockers, calcium channel blockers, higher concentrations of inhalational anesthetics etc.
- Trial name
- NCT05829148
- Testing
- Dexmedetomidine, Melatonin, Pregabalin
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Egymedicalpedia
Sleep Disorders
Clinical Trial on a Food Supplement With Melatonin and Herbal Products to Improve Sleep Quality
A randomized, double-blind, placebo-controlled clinical trial on the ability of a dietary supplement containing melatonin and herbal products to improve sleep quality in subjects with insomnia problems with a 15-day follow-up…
- Trial name
- NCT05459272
- Testing
- Aquilea Sueno Forte
- Where
- Spain
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Uriach Consumer Healthcare
Sleep Disorder (Healthy Volunteers)
Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
Primary Objective: To estimate the range of improvement of NOVANUIT® triple action on sleep quality global score. Secondary Objectives: To estimate the range of improvement of NOVANUIT® triple action on following parameters: time…
- Trial name
- NCT03514732
- Testing
- MELATONIN (MELATL07959)
- Where
- Poland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sanofi
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.
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
Sleep Initiation and Maintenance Disorders
Efficacy and Safety of KI1001 in ≥ 55 Years Old Insomnia Patients
KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy to improve sleep quality in over 55 years old primary insomnia patients.
- Trial name
- NCT01450228
- Testing
- KI1001
- Where
- 10 sites in South Korea
- Volunteers
- 170 people
- Sponsor
- Kuhnil Pharmaceutical Co., Ltd.