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Extended-Release Melatonin for REM Sleep Behavior Disorder
N/A
Recruiting
Led By Emir Festic, MD, MS
Research Sponsored by Mayo Clinic
Eligibility 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4 weeks
Awards & highlights
Study Summary
This trial will compare the effectiveness of two types of melatonin supplements in people with Parkinson's disease and a sleep disorder.
Who is the study for?
This trial is for individuals with Parkinson's disease who also have REM Sleep Behavior Disorder and are listed in the Mayo Clinic Florida's Parkinson's database. It excludes those using other sleep aids like Clonazepam, unwilling to stop these medications for a week before starting the trial, or not consenting to research participation.Check my eligibility
What is being tested?
The study aims to compare two forms of melatonin: immediate-release versus extended-release, to see which one better improves sleep in patients with Parkinson’s and REM Sleep Behavior Disorder.See study design
What are the potential side effects?
Melatonin may cause drowsiness during daytime, mood changes, headaches, dizziness, stomach discomfort or cramps. These side effects can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Parkinson's disease and a sleep disorder where I act out dreams.
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
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,190 Previous Clinical Trials
3,758,047 Total Patients Enrolled
Emir Festic, MD, MSPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Parkinson's disease and a sleep disorder where I act out dreams.I am willing to stop my current treatments for 1 week.I am currently using sleep aids or medications like Clonazepam.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Release Melatonin, Then Extended Release Melatonin
- Group 2: Extended Release Melatonin, Then Immediate Release Melatonin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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