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NCT06590662: SOLR-IH
Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
Phase 2 trial testing Solriamfetol in Idiopathic Hypersomnia in 60 participants. Not yet recruiting.
15 November 2026
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 15 September 2024 |
| Primary completion | 15 November 2026 |
| Estimated completion | 1 June 2027 |
| Sites | 1 location across France |
Drugs / interventions tested
- Solriamfetol — full drug profile →
- Placebo
Conditions studied
- Idiopathic Hypersomnia — all drugs for Idiopathic Hypersomnia →
Sponsor
University Hospital, Montpellier
Who can join
Adults 18 to 60, any sex, with Idiopathic Hypersomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients. Patients will be randomized (1:1) to receive either solriamfetol or placebo, with titration, every morning upon awakening during all treatment periods (Day 0 to Week 7).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Idiopathic hypersomnia is a 24-hour disorder.
Foldvary-Schaefer N, Maski K, Schneider LD, Dauvilliers Y. · · 2025 · cited 1× · PMID 41678063 · DOI 10.1007/s44470-025-00007-1
Verify or expand the search:
- PubMed search for NCT06590662
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Solriamfetol
Trials testing the same drug.
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- NCT06404086 — RECOVER-SLEEP: Platform Protocol · Phase 2 · completed
- NCT06170970 — Solriamfetol for the Treatment of Multiple Sclerosis Fatigue · Phase 2 · recruiting
- NCT06103825 — A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy · Phase 3 · completed
- NCT04602936 — Solriamfetol in Binge Eating Disorder · Phase 4 · unknown
Other recruiting trials for Idiopathic Hypersomnia
Currently open trials in the same condition.
- NCT07096674 — A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia · Phase 2 · recruiting
- NCT06812078 — A Study of TAK-360 in Adults With Idiopathic Hypersomnia · Phase 2 · recruiting
- NCT06457945 — Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions · NA · recruiting
- NCT06484348 — Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcol · NA · recruiting
- NCT06252571 — a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospect · Phase 2 · recruiting
Other University Hospital, Montpellier trials
Trials by the same sponsor.
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- NCT07255495 — Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism · NA · not yet recruiting
- NCT07534189 — Prospective Cohort Study Evaluating a Thermal Spa Programme in Symptomatic Knee Osteoarthritis · NA · not yet recruiting
- NCT07515638 — Immun4Cure Cohort of Autoimmune Diseases · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06590662 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06590662.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing