Melatonin in Adults With SMS (NCT03492970) | Clinical Trial Compass
CompletedNot Applicable
Melatonin in Adults With SMS
France10 participantsStarted 2018-03-07
Plain-language summary
Sleep-Wake and behavioral disorders in Smith Magenis Syndrome (SMS) are strongly linked to an inversion of the nychtemeral secretion of melatonin. This inversion have been described in children with SMS. However its evolution during adulthood remains unknown. The aim of this study is to assess 24hours melatonin levels in 10 adults with SMS in order to optimize medication in adults with SMS
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with Smith Magenis Syndrome aged 18 years or older
* subject or guardian having signed the consent
Exclusion Criteria:
* Pregnant women
* Minor subject
* Diagnosis of Smith Magenis syndrome not certain
* Taking benzodiazepines or related substances
* Taking betablockers
* Major behavioral disorders versus indicating participation in this study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already been completed and was measuring 24-hour melatonin levels in adults with Smith-Magenis Syndrome, has my doctor seen the results, and what did they show about whether melatonin treatment helped regulate the inverted sleep-wake cycle typical in SMS?
2Smith-Magenis Syndrome involves an unusual daytime spike in melatonin rather than a nighttime one — so could my doctor explain how the melatonin dosing in this trial was designed to work around that, and whether that approach might be worth trying in my case?
3Since this was listed as Phase NA, meaning it wasn't a standard drug-approval trial, does that change how confident my doctor is in applying the findings to my treatment, and what level of evidence now exists for melatonin use in adults with SMS specifically?
4Are there standard-of-care options for managing the sleep disturbances in SMS that my doctor would recommend trying before or alongside anything informed by this trial's findings?
5Given that this trial focused on adults with SMS, how relevant are its results to my specific situation — and is my doctor aware of any ongoing or newer studies that might build on what this completed trial found?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.