Phase 3
N=201
A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
Narcolepsy With Cataplexy
Bottom Line
View on ClinicalTrials.gov: NCT03030599 ↗Enrolled (actual)
201
Serious AEs
2.6%
Results posted
Nov 2020
Primary outcome: Primary: Change in Weekly Number of Cataplexy Attacks — 0.00; 2.35 attacks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- JZP-258 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weekly Number of Cataplexy Attacks |
0.00; 2.35 | — |
| SECONDARY Change in the Epworth Sleepiness Scale (ESS) Score |
0.00; 2.0 | — |
| SECONDARY Number of Participants With Worsening Patient Global Impression of Change (PGIc) for Narcolepsy Overall |
3; 29 | — |
| SECONDARY Number of Participants With Worsening Clinical Global Impression of Change (CGIc) for Narcolepsy Overall |
4; 39 | — |
| SECONDARY Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Scores |
-0.03; -1.92; 1.55; -1.92 | — |
| SECONDARY Change in 5-level EQ-5D (EQ-5D-5L) Crosswalk Index Score and Visual Analog Scale |
0.00; 0.00; 0.00; -5.00 | — |
Summary
This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between 18 and 70 years of age, inclusive.
- 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.
- 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.
- Willing and able to comply with the study design schedule and other requirements.
- Willing and able to provide written informed consent.
Exclusion Criteria
- Narcolepsy secondary to another medical condition (e.g., CNS injury or lesion)
- 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.
- 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).
- 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.
- Unsafe for the subject to receive placebo treatment for 2 weeks, in the opinion of the Investigator.
Data sourced from ClinicalTrials.gov (NCT03030599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.