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.
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:
- Is 18 to 64 years of age inclusive at the time of signing the informed consent.
- Has a physician diagnosis of NT1 according to ICSD-3-TR criteria
- 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.
- 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).
- Participant agrees to the following based on sex assigned at birth.
- 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
- 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.
- Is capable of giving signed informed consent
Participants are excluded from the study if any of the following criteria apply:
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than NT1 that is associated with EDS.
- 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.
- Presence of severe renal impairment, end-stage renal disease or BSA-adjusted calculated eGFR <60 mL/min.
- Presence of cardiodynamic abnormalities defined as triplicate 12-lead ECG
- 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.
- 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.
- 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).
- Laboratory values (chemistry, hematology, and urinalysis) outside the laboratory reference range considered to be clinically significant by the investigator.
- 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).
- 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.
- Current or history of psychotic or bipolar disorders, or any first degree relative with a history of schizophrenia-spectrum disorder or bipolar I disorder.
- 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.
- History of seizure disorder or a physical condition that would increase seizure risk.
- History of ischemic event or a condition that elevates the participant's risk for an ischemic event
- Evidence of untreated or inadequately treated sleep-disordered breathing
- Concomitant or recent (within 5 half-lives) use of drugs that affect QT or QRS intervals, including sodium channel blockers.
- 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.
- Concomitant use of XYWAV, high sodium oxybate, or pitolisant. Other medications used for treatment of cataplexy (eg, antidepressants) are allowed.
- 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.
- Habitual bedtime later than 1:00 AM over the last 6 months, per self-report.
- Occupation requiring nighttime shift work or variable shift work.
- 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
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 group | Role | What they receive |
|---|---|---|
| JZP441 Dose Level 1 | Experimental | Participants with narcolepsy type 1 who are randomized to receive JZP441. Receives: Drug: JZP441 |
| JZP441 Dose Level 2 | Experimental | Participants with narcolepsy type 1 who are randomized to receive JZP441. Receives: Drug: JZP441 |
| JZP441 Dose Level 3 | Experimental | Participants with narcolepsy type 1 who are randomized to receive JZP441. Receives: Drug: JZP441 |
| Placebo | Placebo comparator | Participants 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.
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)
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
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.
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.
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.
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
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.
- First posted7 May 2025
- Study start13 May 2025
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
Why it stopped: The study was terminated based on a business decision by the Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jazz Pharmaceuticals Ireland Limited
- Responsible party
- Sponsor
- Investigators
- Global Medical Lead, Study director, Jazz Pharmaceuticals
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06961266
- Acronym / sponsor ID
- JZP441-105
- Conditions
- Narcolepsy
- Keywords
- Narcolepsy Type 1, JZP441
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated based on a business decision by the Sponsor.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Jazz Pharmaceuticals Ireland Limited
- Study start
- 13 May 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, placebo-controlled crossover study
| Arm | Type | Receives |
|---|---|---|
| JZP441 Dose Level 1 | Experimental | Drug: JZP441Participants with narcolepsy type 1 who are randomized to receive JZP441. |
| JZP441 Dose Level 2 | Experimental | Drug: JZP441Participants with narcolepsy type 1 who are randomized to receive JZP441. |
| JZP441 Dose Level 3 | Experimental | Drug: JZP441Participants with narcolepsy type 1 who are randomized to receive JZP441. |
| Placebo | Placebo comparator | Drug: Matching PlaceboParticipants with narcolepsy type 1 who are randomized to receive matching placebo. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JZP441Administered orally | Drug | JZP441 Dose Level 1, JZP441 Dose Level 2, JZP441 Dose Level 3 |
| Matching PlaceboAdministered orally | Drug | Placebo |
Primary outcome
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
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.
6 secondary outcomes
Number of Participants Reporting Treatment-emergent Adverse Events
Time frame: Baseline up to Week 11
Pharmacokinetic Parameter Maximum Plasma Concentration
Time frame: Day 1 (predose), 2, 4, 6, 8, 10, and 12 hours post first dose; Day 2 (24 hours) post first dose.
Pharmacokinetic Parameter Time to Maximum Plasma Concentration
Time frame: Day 1 (predose), 2, 4, 6, 8, 10, and 12 hours post first dose; Day 2 (24 hours) post first dose.
Pharmacokinetic Parameter Area Under the Plasma Concentration Curve
Time frame: Day 1 (predose), 2, 4, 6, 8, 10, and 12 hours post first dose; Day 2 (24 hours) post first dose.
Mean Score of the First 4 assessments of Karolinska Sleepiness Scale
Time frame: 1, 3, 5, 7, 9 and 11 hours after first dose
Mean VAS Score For Sleepiness
Time frame: 1, 3, 5, 7, 9 and 11 hours after first dose
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Medical Lead study director
Jazz Pharmaceuticals
4 sites in 1 country: see every site and its status.
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.