Sleep Disturbances in Smith-Magenis SyndromeNCT03154697
Development of Clinical Database of Individuals With Smith-Magenis Syndrome and Sleep Disturbances
An observational study of Sleep Disturbances in Smith-Magenis Syndrome, run by Vanda Pharmaceuticals at 1 site in United States.
Trial summary
This database will be used to better understand the sleep problems of people with SMS. This clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an awareness campaign around SMS and the sleep disturbances that are characteristic of the disorder. Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Sleep Disturbances in Smith-Magenis Syndrome
- What is being tested?
- Data collection of sleep disturbances in individuals with SMS
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with SMS
Who may be able to join
- Parent or legal guardian of individual with Smith-Magenis Syndrome
Who cannot join
- Not legal guardian of individual with SMS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanda Pharmaceuticals
Washington D.C., District of Columbia, 20037
Vanda Pharmaceuticals, 202-734-3400
About this study
Official title: Development of Clinical Database of Individuals With Smith-Magenis Syndrome
This database will be used to better understand the sleep problems of people with SMS. This clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an awareness campaign around SMS and the sleep disturbances that are characteristic of the disorder.
- Being tested
- Data collection of sleep disturbances in individuals with SMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection of sleep disturbances in individuals with SMSOther
Data related to Smith-Magenis syndrome and sleep disturbances are collected through a web or phone survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of individuals with Smith- Magenis syndrome
Measured: 5 years
Secondary outcomes (1)
Sleep Disturbances
Measured: Up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startJan 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disturbances in Smith-Magenis SyndromeStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154697
- Sponsor's protocol ID
- Pro00015678
- Status last verified
- Oct 2018
- First submitted
- 16 Mar 2017
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Clinical Database of Individuals With Smith-Magenis Syndrome
- ClinicalTrials.gov ID
- NCT03154697
- Acronym / sponsor ID
- Pro00015678
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This database will be used to better understand the sleep problems of people with SMS. This clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an awareness campaign around SMS and the sleep disturbances that are characteristic of the disorder.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with SMS
Key inclusion criteria (1 listed)
- Parent or legal guardian of individual with Smith-Magenis Syndrome
Key exclusion criteria (1 listed)
- Not legal guardian of individual with SMS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection of sleep disturbances in individuals with SMSData related to Smith-Magenis syndrome and sleep disturbances are collected through a web or phone survey | Other | – |
Primary outcome
Number of individuals with Smith- Magenis syndrome
Time frame: 5 years
1 secondary outcome
Sleep Disturbances
Time frame: Up to 100 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
Related trials for Sleep Disturbances in Smith-Magenis Syndrome
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disturbances in Smith-Magenis Syndrome, run by Vanda Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals (202-734-3400, clinicaltrials@vandapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of individuals with Smith- Magenis syndrome (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.