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NarcolepsyPhase 1NCT06961266

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

A Phase 1 study testing JZP441 in people with Narcolepsy, run by Jazz Pharmaceuticals at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Narcolepsy
What is being tested?
JZP441
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
4 sitesUnited States
Study dates
13 May 2025to 29 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Is 18 to 64 years of age inclusive at the time of signing the informed consent.
  2. Has a physician diagnosis of NT1 according to ICSD-3-TR criteria
  3. Has an average sleep latency of less than 15 minutes, as documented by the mean of the first 4 trials of the Baseline MWT, as determined by central assessment.
  4. Has a minimum body weight of 50 kg for men and 45 kg for women and a BMI within the range 18.0 to 35.0 kg/m^2 (inclusive).
  5. Participant agrees to the following based on sex assigned at birth.
  6. Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 90 days after the last dose of study intervention:
  • Refrain from donating sperm
  • Use contraception /barrier as specified in the protocol
  1. Female participants are eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
  • Is a woman of non-childbearing potential (WONCBP) OR
  • Is a WOCBP and using a contraceptive method that is highly effective during the study intervention period and until completion of the Safety Follow-up Period.
  • Male partners of WOCBP are required to use barrier protection, (eg, condoms) during the study intervention period and over the 90-day period after the last dose of study intervention.
  • A WOCBP must have a negative highly sensitive pregnancy test at screening and at check-in on Day -1 of each Treatment Visit, before the first dose of study intervention is administered.
  • If a urine test cannot be confirmed as negative, a serum pregnancy test is required.
  1. Is capable of giving signed informed consent

Participants are excluded from the study if any of the following criteria apply:

  1. Any other clinically relevant medical, behavioral, or psychiatric disorder other than NT1 that is associated with EDS.
  2. History or presence of gastrointestinal (including gastric bypass surgery within the past 10 years), hepatic disease, untreated thyroid disease, or any other condition that may interfere with absorption, distribution, metabolism, or excretion of drugs.
  3. Presence of severe renal impairment, end-stage renal disease or BSA-adjusted calculated eGFR <60 mL/min.
  4. Presence of cardiodynamic abnormalities defined as triplicate 12-lead ECG
  5. History or evidence of any of the following: myocardial infarction, cardiac surgery revascularization, unstable angina, cerebrovascular accident or stroke or TIA, pacemaker, atrial fibrillation, flutter, syncope in the past 2 years from a cardiac etiology or unexplained syncope or non-sustained or sustained VT. Angina pectoris greater than Class 1, CHF greater than NYHA Class 1, personal or family history of the Long QT Syndrome, Brugada syndrome, Wolff-Parkinson-White syndrome, any history of heart block, family history of sudden death.
  6. Structural or functional heart abnormalities as determined by an echocardiogram performed within 6 months prior to screening, including LVEF <45%; moderate or greater aortic or mitral stenosis or regurgitation.
  7. Presence or history of uncontrolled hypertension, systolic BP of at least 140 mmHg or diastolic BP of at least 90 mmHg (at Screening Visit, Baseline Visit, or prior to randomization).
  8. Laboratory values (chemistry, hematology, and urinalysis) outside the laboratory reference range considered to be clinically significant by the investigator.
  9. History of suicide attempt, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to item 4 or item 5 on the C-SSRS (within the past 6 months).
  10. Current major depressive episode or presence of uncontrolled anxiety disorder according to DSM-5 criteria. Participants with stable treated depression and/or anxiety are allowed.
  11. Current or history of psychotic or bipolar disorders, or any first degree relative with a history of schizophrenia-spectrum disorder or bipolar I disorder.
  12. History (within the past year at screening) or presence of substance use disorder or alcohol use disorder per DSM-5 definition, known drug dependence, or seeking treatment for alcohol or substance use related disorder.
  13. History of seizure disorder or a physical condition that would increase seizure risk.
  14. History of ischemic event or a condition that elevates the participant's risk for an ischemic event
  15. Evidence of untreated or inadequately treated sleep-disordered breathing
  16. Concomitant or recent (within 5 half-lives) use of drugs that affect QT or QRS intervals, including sodium channel blockers.
  17. Use of any medications that could affect the evaluation of EDS within a time period prior to the Baseline Visit corresponding to at least 5 half-lives of the drug(s) or planned use during the study.
  18. Concomitant use of XYWAV, high sodium oxybate, or pitolisant. Other medications used for treatment of cataplexy (eg, antidepressants) are allowed.
  19. Participation in another clinical study of an investigational drug (other than JZP441) or medical device within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention and throughout the duration of the study.
  20. Habitual bedtime later than 1:00 AM over the last 6 months, per self-report.
  21. Occupation requiring nighttime shift work or variable shift work.
  22. Travel across 3 or more time zones within 1 week of Baseline Visit or planned through duration of treatment.

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Clinical Trial Site

    Atlanta, Georgia, 30328

  • Clinical Trial Site

    Austin, Texas, 78731

  • Clinical Trial Site

    Cincinnati, Ohio, 45245

  • Clinical Trial Site

    Columbia, South Carolina, 29201

Other trials in United States

About this study

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

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.

Read the 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
Being tested
JZP441, Matching Placebo
Keywords
Narcolepsy Type 1, JZP441
Medical subject headings
Narcolepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JZP441Drug

    Administered orally

  • Matching PlaceboDrug

    Administered orally

Study groups in NCT06961266
Study groupRoleWhat they receive
JZP441 Dose Level 1ExperimentalParticipants with narcolepsy type 1 who are randomized to receive JZP441.
Receives: Drug: JZP441
JZP441 Dose Level 2ExperimentalParticipants with narcolepsy type 1 who are randomized to receive JZP441.
Receives: Drug: JZP441
JZP441 Dose Level 3ExperimentalParticipants with narcolepsy type 1 who are randomized to receive JZP441.
Receives: Drug: JZP441
PlaceboPlacebo comparatorParticipants with narcolepsy type 1 who are randomized to receive matching placebo.
Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean sleep latency of the first 4 sessions of the Maintenance of Wakefulness Test

    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.

    Measured: 1, 3, 5, and 7 hours after the first dose of study intervention

Secondary outcomes (6)
  1. Number of Participants Reporting Treatment-emergent Adverse Events

    A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that started, or worsened in severity or seriousness, following a dose of study intervention.

    Measured: Baseline up to Week 11

  2. Pharmacokinetic Parameter Maximum Plasma Concentration

    Measured: Day 1 (predose), 2, 4, 6, 8, 10, and 12 hours post first dose; Day 2 (24 hours) post first dose.

  3. Pharmacokinetic Parameter Time to Maximum Plasma Concentration

    Measured: Day 1 (predose), 2, 4, 6, 8, 10, and 12 hours post first dose; Day 2 (24 hours) post first dose.

  4. Pharmacokinetic Parameter Area Under the Plasma Concentration Curve

    Measured: Day 1 (predose), 2, 4, 6, 8, 10, and 12 hours post first dose; Day 2 (24 hours) post first dose.

  5. Mean Score of the First 4 assessments of Karolinska Sleepiness Scale

    The Karolinska Sleepiness Scale (KSS) is a single-item, 9-point, self-administered questionnaire that measures a participant's subjective level of sleepiness (from "extremely alert" to "extremely sleepy, can't keep awake"). Scores generally decrease with longer periods of wakefulness, indicating that lower scores correlate with better outcomes.

    Measured: 1, 3, 5, 7, 9 and 11 hours after first dose

  6. Mean VAS Score For Sleepiness

    The self-reported VAS measure of sleepiness in the current study will be a retrospective measure of how sleepy the participant felt throughout the day, with anchors at each end of the line labeled as "0=not at all sleepy" to "100=very sleepy." Higher VAS scores indicate worse outcome.

    Measured: 1, 3, 5, 7, 9 and 11 hours after first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study start13 May 2025
  3. Primary completion29 Jan 2026
  4. Study completion29 Jan 2026

Why it stopped: The study was terminated based on a business decision by the Sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized, placebo-controlled crossover study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06961266
Sponsor's protocol ID
JZP441-105
Status last verified
Mar 2026
First submitted
29 Apr 2025
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JZP441 in people with Narcolepsy, run by Jazz Pharmaceuticals at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated based on a business decision by the Sponsor.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean sleep latency of the first 4 sessions of the Maintenance of Wakefulness Test (time frame: 1, 3, 5, and 7 hours after the first dose of study intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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