Condition (MeSH)
Idiopathic Hypersomnia
ClinicalTrials.gov lists 52 trials for Idiopathic Hypersomnia or a narrower condition beneath it.
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Trials per phase
52 of the 52 trials are tagged with Idiopathic Hypersomnia itself; the rest are tagged with a narrower condition beneath it.
When did Idiopathic Hypersomnia trials start? (14)
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 1/2
- Phase 2
- Phase 2/3
- Phase 3
- Phase 4
- Not applicable
- Observational
Top of scale: 10
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 |
|---|---|
| 2026 (partial year) | 6 |
| 2025 | 8 |
| 2024 | 10 |
| 2023 | 2 |
| 2022 | 6 |
| 2021 | 4 |
| 2020 | 2 |
| 2019 | 3 |
| 2018 | 4 |
| 2017 | 1 |
Showing 10 of 14 earlier years.
Forecast of the full-year count, planned starts included, not rows of this table: about 8 trials starting in 2026 and about 8 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.
Prediction, not a registry value: median of 30 months from start to primary completion across 13 trials still running at the 2026-10-09 snapshot; registered median of 19 months across 25 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
What phase are Idiopathic Hypersomnia trials in? (8)
Shown in this order: phase order.
Show the trials by phase as a table
| Phase | Trials |
|---|---|
| Phase 1 | 2 |
| Phase 1/2 | 1 |
| Phase 2 | 12 |
| Phase 2/3 | 3 |
| Phase 3 | 6 |
| Phase 4 | 3 |
| Not applicable | 14 |
| Observational | 11 |
How many Idiopathic Hypersomnia trials are recruiting? (7)
Shown in this order: the order a trial moves through, from not yet recruiting to unknown.
| Status | Trials |
|---|---|
| Not yet recruiting | 5 |
| Recruiting | 16 |
| Enrolling by invitation | 1 |
| Active, not recruiting | 1 |
| Completed | 25 |
Showing 5 of 7 statuses.
Status as registered on ClinicalTrials.gov. Each trial is counted once.
Which lead sponsors run the most Idiopathic Hypersomnia trials? (7)
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 |
|---|---|
| Harmony Biosciences Management, Inc. | 3 |
| Jazz Pharmaceuticals | 3 |
| Alkermes, Inc. | 2 |
| Balance Therapeutics | 2 |
| Centessa Pharmaceuticals (UK) Limited | 2 |
Showing 5 of 7 sponsors.
Which drugs are being tested for Idiopathic Hypersomnia? (1)
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 |
|---|---|
| ALKS 2680 | 2 |
Interventions as named in the registry (14)
Shown in this order: most trials first.
| Drug | Trials |
|---|---|
| TAK-360 | 2 |
| ORX750 | 2 |
| Low Sodium Oxybate | 2 |
| Amphetamine-Dextroamphetamine | 1 |
| citrate of caffeine | 1 |
Showing 5 of 14 interventions.
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 Idiopathic Hypersomnia trials report? (10)
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 |
|---|---|---|
| Syncope | 3 | 2 |
| Nephrolithiasis | 2 | 1 |
| Non-cardiac chest pain | 2 | 1 |
| Pyelonephritis | 2 | 1 |
| Rhabdomyolysis | 2 | 1 |
Showing 5 of 10 adverse events.
Which publications cover Idiopathic Hypersomnia? (16)
Shown in this order: major-topic papers first, then newest, then most linked to trials.
| Publication | Journal | Year | Major topic |
|---|---|---|---|
| Effects of low-sodium oxybate on diary-based sleep time in a clinical study in adults with idiopathic hypersomnia. | Sleep medicine | 2026 | Yes |
| A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia. | Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine | 2025 | Yes |
| Efficacy and Safety of Sodium Oxybate in Adults With Idiopathic Hypersomnia: A Randomized Controlled Trial. | Neurology | 2025 | Yes |
| Guardians of Rest? Investigating the gut microbiota in central hypersomnolence disorders. | Sleep medicine | 2024 | Yes |
| Brain fog in central disorders of hypersomnolence: a review. | Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine | 2024 | Yes |
Showing 5 of 16 publications.
Prevalence (6)
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 |
|---|---|---|---|---|---|
| Idiopathic hypersomnia | Point prevalence | 1-5 / 10 000 | Europe | Not stated | Exact |
| Idiopathic hypersomnia | Point prevalence | Unknown | Worldwide | Not stated | Exact |
| Idiopathic hypersomnia | Point prevalence | Unknown | Worldwide | Not stated | Unspecified |
| Idiopathic hypersomnia | Point prevalence | 1-5 / 10 000 | Europe | Not stated | Exact |
| Idiopathic hypersomnia | Point prevalence | 1-5 / 10 000 | Europe | Not stated | Unspecified |
Showing 5 of 6 prevalence observations.
Rare-disease identity (2)
Shown in this order: exact, broader, narrower, other.
| Orphanet disease | ORPHA code | Relation | Source |
|---|---|---|---|
| Idiopathic hypersomnia | 33208 | Exact | Orphadata Science knowledge files, Product 1 |
| Idiopathic hypersomnia | 33208 | 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.