Condition (MeSH)
Smith-Magenis Syndrome
ClinicalTrials.gov lists 17 trials for Smith-Magenis Syndrome or a narrower condition beneath it. Vanda Pharmaceuticals has the most among industry and government lead sponsors, with 3.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Trials per phase
17 of the 17 trials are tagged with Smith-Magenis Syndrome itself; the rest are tagged with a narrower condition beneath it.
When did Smith-Magenis Syndrome trials start? (13)
Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Trials over time, by phase
- Phase 1
- Phase 2
- Phase 2/3
- Phase 3
- Not applicable
- Observational
Top of scale: 3
Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.
| Year | Trials started |
|---|---|
| 2024 | 1 |
| 2022 | 1 |
| 2021 | 1 |
| 2018 | 3 |
| 2017 | 1 |
| 2016 | 1 |
| 2015 | 1 |
| 2014 | 1 |
| 2013 | 3 |
| 2007 | 1 |
Showing 10 of 13 earlier years.
No forecast is made for this condition: it averages 0.4 trial starts a year over the five years to September, under the 5 a year the method needs.
Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
What phase are Smith-Magenis Syndrome trials in? (6)
Shown in this order: phase order.
Show the trials by phase as a table
| Phase | Trials |
|---|---|
| Phase 1 | 3 |
| Phase 2 | 1 |
| Phase 2/3 | 1 |
| Phase 3 | 1 |
| Not applicable | 6 |
| Observational | 5 |
How many Smith-Magenis Syndrome trials are recruiting? (5)
Shown in this order: the order a trial moves through, from not yet recruiting to unknown.
| Status | Trials |
|---|---|
| Recruiting | 1 |
| Enrolling by invitation | 1 |
| Completed | 11 |
| Terminated | 1 |
| Unknown status | 3 |
Status as registered on ClinicalTrials.gov. Each trial is counted once.
Which lead sponsors run the most Smith-Magenis Syndrome trials? (6)
Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.
| Sponsor | Trials |
|---|---|
| Vanda Pharmaceuticals | 3 |
| National Human Genome Research Institute (NHGRI) | 2 |
| Neurim Pharmaceuticals Ltd. | 2 |
| Basque Health Service | 1 |
| National Institute of Neurological Disorders and Stroke (NINDS) | 1 |
Showing 5 of 6 sponsors.
Which drugs are being tested for Smith-Magenis Syndrome? (2)
Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.
| Drug | Trials |
|---|---|
| Tasimelteon | 2 |
| Setmelanotide | 1 |
Interventions as named in the registry (4)
Shown in this order: most trials first.
| Drug | Trials |
|---|---|
| Melatonin PR | 4 |
| acylated and unacylated ghrelin dosages | 1 |
| Hourly dosing of the nychtemeral secretion of melatonin | 1 |
| dTR Melatonin (NIH CC PDS) | 1 |
These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.
Which serious adverse events do Smith-Magenis Syndrome trials report? (9)
Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.
| Adverse event | Subjects affected | Trials |
|---|---|---|
| SAE -Serious adverse event | 4 | 1 |
| SAE - Serious adverse event | 3 | 1 |
| Acute Myocardial Infarction | 2 | 1 |
| Diverticulitis | 1 | 1 |
| Gastrointestinal Haemorrhage | 1 | 1 |
Showing 5 of 9 adverse events.
Which publications cover Smith-Magenis Syndrome? (6)
Shown in this order: major-topic papers first, then newest, then most linked to trials.
| Publication | Journal | Year | Major topic |
|---|---|---|---|
| Children with neurodevelopmental disorders: how do they sleep? | Current opinion in psychiatry | 2022 | Yes |
| Retinoic acid-induced 1 gene haploinsufficiency alters lipid metabolism and causes autophagy defects in Smith-Magenis syndrome. | Cell death & disease | 2022 | Yes |
| Venetoclax for Patients With Chronic Lymphocytic Leukemia With 17p Deletion: Results From the Full Population of a Phase II Pivotal Trial. | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 2018 | Yes |
| Development of a prognostic model for overall survival in multiple myeloma using the Connect<sup>®</sup> MM Patient Registry. | British journal of haematology | 2019 | No |
| The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL. | Blood | 2018 | No |
Showing 5 of 6 publications.
Prevalence (15)
Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.
| Orphanet disease | Type | Class | Geography | Jurisdiction | Mapping relation |
|---|---|---|---|---|---|
| Smith-Magenis syndrome | Point prevalence | 1-9 / 100 000 | United States | US | Exact |
| Smith-Magenis syndrome | Point prevalence | 1-9 / 100 000 | United States | US | Unspecified |
| Smith-Magenis syndrome | Prevalence at birth | 1-9 / 100 000 | United States | US | Unspecified |
| Smith-Magenis syndrome | Point prevalence | 1-9 / 100 000 | United States | US | Exact |
| Smith-Magenis syndrome | Prevalence at birth | 1-9 / 100 000 | United States | US | Exact |
Showing 5 of 15 prevalence observations.
Rare-disease identity (2)
Shown in this order: exact, broader, narrower, other.
| Orphanet disease | ORPHA code | Relation | Source |
|---|---|---|---|
| Smith-Magenis syndrome | 819 | Exact | Orphadata Science knowledge files, Product 1 |
| Smith-Magenis syndrome | 819 | Exact | Orphanet Rare Disease Ontology (ORDO) |
Not on this page
Not measured: delivery record.
Checked, with nothing recorded for this condition: sub-conditions in mesh.