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NCT06961266 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Narcolepsy, sponsored by Jazz Pharmaceuticals.

Compiled by PlainTrial · August 8, 2026

Recruiting
Registry status: Phase 1
Development phase: 8
Enrollment target: 4
Study locations

NCT06961266: Recruiting Phase 1 study of Narcolepsy, sponsored by Jazz Pharmaceuticals.

NCT06961266 is a Phase 1 study of Narcolepsy that is actively recruiting participants, run by Jazz Pharmaceuticals. The registered enrollment target is 8 participants, below the 380-participant average among 12 other Narcolepsy trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06961266, a Phase 1 study of Narcolepsy, is actively recruiting participants, sponsored by Jazz Pharmaceuticals.

RECRUITING
Registry status: Phase 1
Development phase: 8 participants
Enrollment target: 4
Study locations

Study 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.

Primary Outcome

The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened quiet environment and is commonly used to assess response to treatment. The MWT will be used to compare the pharmacodynamic response of JZP441 versus placebo. Sleep latency will be reported in minutes.

Conditions Studied

Narcolepsy

Interventions

DRUG Matching Placebo
DRUG JZP441

Study Locations (4)

Georgia

Clinical Trial Site - Atlanta

Ohio

Clinical Trial Site - Cincinnati

South Carolina

Clinical Trial Site - Columbia

Texas

Clinical Trial Site - Austin

Trial Details

Field	Value
Enrollment Target	8 participants
Start Date	2025-05-13
Est. Completion	2026-04-01
Phase	Phase 1

Jazz Pharmaceuticals

128 total trials

What NCT06961266 shows while recruiting

NCT06961266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 380-participant average among 12 other Narcolepsy trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Narcolepsy appearing as the primary indexed condition, and to 2 interventions - of which Matching Placebo is the first listed.

NCT06961266 reports a single indexed study location in Georgia, Ohio, South Carolina.

Frequently Asked Questions

What is clinical trial NCT06961266 about?

NCT06961266 is a clinical study titled "A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1". 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...

What is the current status of trial NCT06961266?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2025-05-13. Estimated completion is 2026-04-01.

What conditions does trial NCT06961266 study?

This clinical trial studies the following conditions: Narcolepsy.

What interventions are being tested in trial NCT06961266?

The interventions under investigation include: Matching Placebo (DRUG), JZP441 (DRUG).

Who is sponsoring clinical trial NCT06961266?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06961266 being conducted?

This trial has 4 study locations across Georgia, Ohio, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Narcolepsy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06961266's enrollment target sits among peer trials

8 12th of 12 higher than 1 of 12 other Narcolepsy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Narcolepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06961266, the US trial registry maintained by the National Library of Medicine. NCT06961266 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.