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

• Status: Completed
• Trial end date: 2019-07-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jazz Pharmaceuticals

Criteria

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 Investigator.

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 Investigator.