RecruitingPhase 3NCT07455383
Neurological
Narcolepsy with Cataplexy
Also known as Type 1 narcolepsy, NT1, hypocretin deficiency syndrome, Gelineau disease
Type 1 narcolepsy (narcolepsy with cataplexy) is caused by autoimmune destruction of hypothalamic hypocretin (orexin)-producing neurons, resulting in CSF hypocretin-1 levels below 110 pg/mL. Clinical tetrad includes excessive daytime sleepi
ORPHA:2073 ↗Gene HCRT (hypocretin/orexin pathway); HLA-DQB1*06:02 associationPrevalence 1-5 per 10,000 (Orphanet)Onset Childhood, Adolescent, AdultAutoimmune (HLA-associated, hypocretin neuron destruction)
8
studies recruiting now
as of 7 Sept 2026
53
studies registered in total
as of 7 Sept 2026
11
countries with a recruiting site
as of 7 Sept 2026
30 Jun 2026
most recent study posted
among recruiting studies
Recruiting trials
RecruitingPhase 3NCT07540364
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)
RecruitingPhase 3NCT07675135
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
RecruitingPhase 2NCT06952699
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
RecruitingPhase 2 / Phase 3NCT07598708
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Showing the 5 most recently updated recruiting studies, as recorded 7 Sept 2026. Live status on each study page.
See all 8 recruiting studiesWhere recruiting studies are running
Countries with at least one recruiting site among the studies above, 7 Sept 2026. Tap a country to search trials there.
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About Narcolepsy with Cataplexy
Type 1 narcolepsy (narcolepsy with cataplexy) is caused by autoimmune destruction of hypothalamic hypocretin (orexin)-producing neurons, resulting in CSF hypocretin-1 levels below 110 pg/mL. Clinical tetrad includes excessive daytime sleepiness, cataplexy (sudden loss of muscle tone triggered by emotion), sleep paralysis, and hypnagogic hallucinations. Approved treatments include sodium oxybate (Xyrem/Lumryz), pitolisant (Wakix), and modafinil/solriamfetol for sleepiness.
Common clinical features
Excessive daytime sleepinessCataplexy triggered by emotionSleep paralysisHypnagogic hallucinationsFragmented nighttime sleepAutomatic behaviorWeight gain
From Orphanet’s phenotype annotations (CC BY 4.0). Not a complete list.
Treatments being studied
10 approved treatments and 2 in clinical development, from Open Targets (CC BY 4.0). Not medical advice.
Approved: Dextroamphetamine Sulfate (Dexampex)Approved: Sodium Oxybate (Lumryz)Approved: Dextroamphetamine Saccharate (Dextroamphetamine saccharate component of mydayis)Approved: Pitolisant Hydrochloride (Ozawade)Approved: Methylphenidate (Cotempla xr-odt)Approved: Solriamfetol Hydrochloride (Sunosi)Approved: Dextroamphetamine (Xelstrym)Approved: Modafinil (Modafinil)Approved: Armodafinil (Armodafinil)Approved: Amphetamine Sulfate (Amphetamine sulfate)
Phase 3Pitolisant (Wakix)
Phase 2Mazindol (Mazanor)
Before you apply
Things trial teams commonly ask about for Narcolepsy with Cataplexy. Not eligibility rules; those are set by each study.
- CSF hypocretin-1 level below 110 pg/mL is the gold standard diagnostic marker for NT1 trials and confirms autoimmune subtype
- Polysomnography followed by Multiple Sleep Latency Test (MSLT) showing mean sleep latency <8 min and 2+ SOREMPs is required
- Current medications (sodium oxybate, stimulants) require washout periods before PSG/MSLT and before enrollment in many trials
- HLA-DQB1*06:02 typing is often performed at screening — presence supports NT1 diagnosis but absence does not exclude
Related conditions
Information, not medical advice. Trial listings are shown as recorded on ClinicalTrials.gov; whether any study is right for you is a decision for you and your clinicians, and eligibility is decided by each research team. Disease information from Orphanet (CC BY 4.0).