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Idiopathic Hypersomnia

Part of Sleep Disorders, Intrinsic

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for Idiopathic Hypersomnia

5 trials tracked for Idiopathic Hypersomnia: 1 in phase 3 or 4 and 1 with published results. The most-cited published study has 67 citations.

5Trials tracked
1Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 3 1 Phase 2 3 Phase 1 1
  1. Phase 3 A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension Completed · 67 cited
  2. Phase 2 Clarithromycin for the Treatment of Hypersomnia Completed
  3. Phase 2 Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia Completed
  4. Phase 2 Flumazenil for the Treatment of Primary Hypersomnia Completed
  5. Phase 1 A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia Completed

Showing the 5 most-cited and recently-updated of 5 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Idiopathic Hypersomnia: what the trials found

Clinical evidence for Idiopathic Hypersomnia includes data from a Phase 3 trial evaluating JZP-258 (N=154). In this study, the mean change in Epworth Sleepiness Scale (ESS) score was 0.7 compared to 7.4 in the control group 1.

In the same Phase 3 trial, the Idiopathic Hypersomnia Severity Scale (IHSS) showed a mean change of 0.0 for JZP-258 versus 14.0 for the comparator 1. Additionally, 12% of participants in the JZP-258 group reported being worse on the Patient Global Impression of Change (PGIc), compared to 52% in the control group 1.

Recent results — preliminary, needs further review

  • Modafinil showed a mean change in ESS score of 5.0 vs 4.4 in a Phase 2 trial (N=44) 2.
  • Clarithromycin followed by placebo did not show statistically significant improvements in Psychomotor Vigilance Task (PVT) reaction times or lapse numbers (p=0.47, p=0.63, and p=0.64 respectively) in a Phase 2 trial (N=26) 3.
  • Flumazenil did not show statistically significant changes in PVT median reaction time (p=0.77), lapse frequency (p=0.51), or duration of lapse domain (p=0.32) in a Phase 2 trial (N=10) 4.
  • TAK-925 was evaluated in a Phase 1 trial (N=28), where 14.8% of participants experienced at least one treatment-emergent adverse event (TEAE) 5.

For the clinician treating this condition

  • JZP-258 demonstrated a lower rate of patients reporting worse outcomes on the PGIc compared to control, and showed a mean change in ESS score of 0.7 1.
  • JZP-258 was associated with an IHSS mean change of 0.0 compared to 14.0 in the comparator group 1.

AI synthesis of 5 cited trials, updated Jun 28, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.