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Narcolepsy

Part of Sleep Disorders, Intrinsic

Subtypes of Narcolepsy

Narcolepsy Type 1 4

6 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Narcolepsy

24 trials tracked for Narcolepsy: 11 in phase 3 or 4 and 5 with published results. The most-cited published study has 250 citations.

24Trials tracked

11Phase 3 & 4

0Recruiting

5With published results

Phase distribution

Phase 4 2 Phase 3 9 Phase 2 8 Phase 1 1 Other / NA 4

Phase 3 "A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA" Completed · 250 cited
Phase 3 "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy" Completed · 193 cited
Phase 4 A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy Completed · 10 cited
Phase 3 Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy Completed · 3 cited
Phase 4 An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy Completed · 2 cited
Phase 3 Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy Completed

Show 18 more trials

Phase 3 Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness Completed
Phase 3 Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder Completed
Phase 3 Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy Completed
Phase 3 Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy Completed
Phase 3 Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Completed
Phase 2 Clarithromycin for the Treatment of Hypersomnia Completed
Phase 2 Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients Completed
Phase 2 Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) Completed
Phase 2 A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy Completed
Phase 2 A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness Completed
Phase 2 A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy Completed
Phase 2 Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy Completed
Phase 2 A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy Completed
Phase 1 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy Completed
N/A Risk of Narcolepsy Associated With Administration of H1N1 Vaccine Completed
N/A Advancing Understanding of Transportation Options Completed
N/A A Study to Collect Information of People With Narcolepsy in Spain Completed
N/A Awareness and Self-Compassion Enhancing Narcolepsy Treatment Completed

Showing the 24 most-cited and recently-updated of 24 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 Updated — new results For clinicians

Narcolepsy: what the trials found

New evidence indicates that JZP258 is associated with significant reductions in blood pressure for patients with narcolepsy, specifically showing decreases in 24-hour average systolic blood pressure (-4.14 mmHg), daytime average systolic blood pressure (-5.08 mmHg), and seated resting average systolic blood pressure (-9.16 mmHg) ¹.

Multiple pharmacological interventions have demonstrated efficacy in managing narcolepsy symptoms. JZP-110 was associated with significant reductions in Epworth Sleepiness Scale (ESS) scores [3, 4] and improved sleep driving performance ¹⁵. FT218 showed significant improvements in Maintenance of Wakefulness Test (MWT) scores (p<0.001), a high proportion of patients reported being much improved on the Clinical Global Impression of Improvement (p<0.001), and a significant reduction in the number of cataplexy attacks ⁵.

Xyrem (sodium oxybate) was shown to improve daytime sleep latency as measured by MWT across multiple trials (p<0.001) ⁷. Armodafinil demonstrated significant improvements in MWT scores (p=0.0024) and Clinical Global Impression of Change (CGI-C) scores (p<0.0001) ¹¹, with long-term safety and tolerability data available for up to 2 years ⁹.

ADX-N05 demonstrated significant improvements in MWT sleep latency compared to placebo, with notable reductions in ESS scores during treatment weeks [14, 17].

Recent results — preliminary, needs further review

TAK-925 showed statistically significant improvements in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at days 1 and 7 (p<0.0001) ²⁰.
SUVN-G3031 was associated with a reduction in ESS scores (p=0.024) and Clinical Global Impression of Severity (p=0.009), though it did not significantly impact MWT results (p=0.734) ¹².
AXS-12 (Reboxetine) showed a significant reduction in the weekly average total number of cataplexy attacks (p<0.001) ¹³.

For the clinician treating this condition

JZP258 is associated with measurable reductions in systolic blood pressure across 24-hour, daytime, and seated resting measurements.
Multiple agents (FT218, Xyrem, Armodafinil, and ADX-N05) have demonstrated statistically significant improvements in MWT scores or sleep latency.
JZP-110 and FT218 are associated with improved clinical outcomes regarding cataplexy and subjective sleepiness scales.

AI synthesis of 9 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.