NCT06961266

A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1

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: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	JZP441	Administered orally
DRUG	Matching Placebo	Administered orally

Timeline

• Start date: 2025-05-13
• Primary completion: 2026-01-29
• Completion: 2026-01-29
• First posted: 2025-05-07
• Last updated: 2026-04-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study