Suspended
Randomized, Double-Blind, Cross-Over Study Comparing the Efficacy of Immediate and Extended-Release Melatonin as a Supplement Affecting the Sleep Cycle in Patients With Parkinson Disease and Rapid Eye Movement Sleep Behavior Disorder
What is being tested
Immediate Release Melatonin
+ Extended Release Melatonin
Dietary Supplement
Who is being recruted
Synucleinopathies+11
+ Basal Ganglia Diseases
+ Mental Disorders
Over 18 Years
+5 Eligibility Criteria
How is the trial designed
Supportive Care Study
Interventional
Study Start: May 2022
Summary
Principal SponsorMayo Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2022
Actual date on which the first participant was enrolled.Enrolled patients with Parkinson disease and previously diagnosed rapid eye movement sleep behavior disorder, who are being treated at Mayo Clinic in Florida, will be randomized to receive either immediate-release melatonin or extended-release melatonin and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks separated by a washout period of 2 weeks.
Official TitleRandomized, Double-Blind, Cross-Over Study Comparing the Efficacy of Immediate and Extended-Release Melatonin as a Supplement Affecting the Sleep Cycle in Patients With Parkinson Disease and Rapid Eye Movement Sleep Behavior Disorder
Principal SponsorMayo Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
SynucleinopathiesBasal Ganglia DiseasesMental DisordersBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesParkinson DiseaseSleep Wake DisordersNeurodegenerative DiseasesREM Sleep Behavior DisorderParasomniasParkinsonian DisordersREM Sleep Parasomnias
Criteria
2 inclusion criteria required to participate
Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder.
Patient registered to Parkinson's disease database of Mayo Clinic Florida.
3 exclusion criteria prevent from participating
Patients who are using other sleep aids or medications (Clonazepam).
Patients who are not willing to undertake 1 week of washout period.
Patients who do not sign a consent for research.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalSubjects will receive extended release melatonin 5 mg orally at 9 pm every night for 4 weeks. After a washout period of 2 weeks, they then receive immediate release melatonin 5 mg orally at 9 pm every night for 4 weeks.
Group II
ExperimentalSubjects will receive immediate release melatonin 5 mg orally at 9 pm every night for 4 weeks. After a washout period of 2 weeks, they then receive extended release melatonin 5 mg orally at 9 pm every night for 4 weeks.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
SuspendedOne Study Center