Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-28 @ 3:21 AM
Study NCT ID:
NCT06961266
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1
Sponsor:
Jazz Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1b, Randomized, Double-blind, Sponsor-Unblinded, Placebo-Controlled 4-Way Crossover Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 in Participants With Narcolepsy Type 1
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Narcolepsy is a sleep disorder in which patients are not able to maintain wakefulness or require treatment to maintain wakefulness during the daytime. Narcolepsy is a lifelong neurologic disease for which no cure has been clinically available. JZP441 is currently being developed for the treatment of narcolepsy type 1 (NT1). This study will assess the safety of efficacy of JZP441 in adult patients with NT1.
Detailed Description:
This Phase 1b, randomized, double-blind, sponsor-unblinded, placebo-controlled 4-way crossover study will evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of a range of JZP441 doses in participants with NT1. Changes in daytime sleepiness will be assessed via objective (MWT) and subjective (KSS, VAS for sleepiness) efficacy measures.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: