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.
- Drug: JZP-258
- Other: Placebo
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.
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