Other
Immediate Release Melatonin for Parkinson's Disease
Mayo Clinic Florida, Jacksonville, FL
Targeting 2 different conditionsImmediate Release Melatonin +1 moreN/ARecruitingLed by Emir Festic, MD, MSResearch Sponsored by Mayo ClinicEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder.
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline and 4 weeks
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will compare the effectiveness of two types of melatonin supplements in people with Parkinson's disease and a sleep disorder.
Eligible Conditions
- Parkinson's Disease
- REM Sleep Behavior Disorder
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have Parkinson's disease and experience rapid eye movement sleep behavior disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in sleep cycle
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Immediate Release Melatonin, Then Extended Release MelatoninExperimental Treatment2 Interventions
Subjects 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.
Group II: Extended Release Melatonin, Then Immediate Release MelatoninExperimental Treatment2 Interventions
Subjects 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.
Find a site
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,048 Previous Clinical Trials
3,484,685 Total Patients Enrolled
Emir Festic, MD, MSPrincipal Investigator
Mayo ClinicMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many human participants are partaking in this clinical experiment?
"Affirmative, the clinical trial is currently in search of participants. It was first announced on May 1st 2022 and its information was most recently updated on May 24th 2022. This medical study requires 50 enrollees from a single site."
Answered by AI
Is there still room available for volunteers in this research endeavor?
"Clinicaltrials.gov confirms that this experiment is recruiting volunteers, with the first posting taking place on May 1st 2022 and being revised as recently as May 24th of the same year."
Answered by AI
Recent research and studies