Trial Search Results

A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Jazz Pharmaceuticals

Stanford Investigator(s):


  • Drug: JZP-258
  • Other: Placebo


Phase 3


Inclusion Criteria:

   1. Male or female subjects between 18 and 70 years of age, inclusive.

   2. Have a primary diagnosis of narcolepsy with cataplexy that meets ICSD-3 criteria or
   DSM-5 criteria, and currently untreated or treated with or without anticataplectics.

   3. If applicable, treated with a stimulant or alerting agent at unchanged doses for at
   least 2 months prior to dosing or not treated with a stimulant or alerting agent.

   4. Willing and able to comply with the study design schedule and other requirements.

   5. Willing and able to provide written informed consent.

Exclusion Criteria:

   1. Narcolepsy secondary to another medical condition (e.g., CNS injury or lesion)

   2. History or presence of any unstable or clinically significant medical condition,
   behavioral or psychiatric disorder (including active suicidal ideation), or history or
   presence of another neurological disorder or surgical history that might affect the
   subject's safety and/or interfere with the conduct of the study in the opinion of the

   3. Treatment with any central nervous system sedating agents, including but not limited
   to benzodiazepines, nonbenzodiazepine anxiolytics/ hypnotics/sedatives, neuroleptics,
   opioids, barbiturates, phenytoin, ethosuximide, or MCT inhibitors, e.g. diclofenac,
   valproate, ibuprofen, within 2 weeks prior to enrollment (discontinuation for the
   purpose of study enrollment is permitted only if considered safe by the Investigator
   and approved by the Medical Monitor).

   4. Treatment with an antidepressant for cataplexy, if the withdrawal of the
   antidepressant during cross-titration with JZP-258 might be unsafe due to prior
   history of depression.

   5. Unsafe for the subject to receive placebo treatment for 2 weeks, in the opinion of the

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study


Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305