NarcolepsyPhase 3NCT02348593
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
A Phase 3 study testing JZP-110 in people with Narcolepsy, run by Jazz Pharmaceuticals at 60 sites in 6 countries.
Trial summary
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Narcolepsy
- What is being tested?
- JZP-110
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 60 sitesin 6 countries
- Study dates
- May 2015to Feb 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Major Inclusion Criteria:
- Males and females between 18 and 75 years of age, inclusive
- Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
- Body mass index from 18 to <45 kg/m2
- Consent to use a medically acceptable method of contraception
- Willing and able to provide written informed consent
Major Exclusion Criteria:
- Female subjects who are pregnant, nursing, or lactating
- Moderate or severe sleep apnea on the baseline PSG.
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
- History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
- History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
- History of bariatric surgery within the past year or a history of any gastic bypass procedure
- Presence or history of significant cardiovascular disease
- Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
- Use of any medications that could affect the evaluation of cataplexy
- Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
- Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
- History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Trial locations and contacts
60 sites in 6 countries.
60 sites in 6 countries
United States45 sites
Emory Sleep Center
Atlanta, Georgia, 30329
NeuroTrials
Atlanta, Georgia, 30342
FutureSearch Trials of Neurology LP
Austin, Texas, 78731
North Coast Clinical Trials Inc.
Beachwood, Ohio, 44122
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Lowcountry Lung Critical Care
Charleston, South Carolina, 29406
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
University of Illinois Chicago, College of Nursing
Chicago, Illinois, 60612
Sleep Management Institute
Cincinnati, Ohio, 45245
Southwest Cleveland Sleep Research Center
Cleveland, Ohio, 44130
Cleveland Clinic
Cleveland, Ohio, 44195
University of Missouri
Columbia, Missouri, 65201
Sleep Med of South Carolina
Columbia, South Carolina, 29201
Ohio Sleep Medicine & Neuroscience Institute
Dublin, Ohio, 43017
Duke University Medical Center
Durham, North Carolina, 27705
Duke University Medical Center
Durham, North Carolina, 27710
Minnesota Lung Center
Edina, Minnesota, 55435
Pulmonary Associates
Glendale, Arizona, 85306
MD Clinical
Hallandale, Florida, 33009
Hickory Research Center
Hickory, North Carolina, 28602
Todd J. Swick
Houston, Texas, 77063
Hickory Research Center, ARSM Research, LLC
Huntersville, North Carolina, 28078
Critical Care Pulmonary & Sleep Associates, LLC
Lakewood, Colorado, 80228
Preferred Research Partners
Little Rock, Arkansas, 72211
So Cal Institute For Respiratory Diseases, Inc.
Los Angeles, California, 90048
Kentucky Research Group
Louisville, Kentucky, 40218
SleepMed of Central Georgia
Macon, Georgia, 31201
New York University Medical center
New York, New York, 10016
Neurocare, Inc.
Newton, Massachusetts, 24590
Pacific Sleep Medicine
Oceanside, California, 92054
SDS Clinical Trials
Orange, California, 92868
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Stanford University Center for Narcolepsy
Redwood City, California, 94063
Sleep Therapy & Research Center
San Antonio, Texas, 78229
Pacific Research Network, Inc.
San Diego, California, 92103
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Swedish Medical Center
Seattle, Washington, 98122
Clayton Sleep Institute
St Louis, Missouri, 63143
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, 33707
Clinical Neurophysiology Services
Sterling Heights, Michigan, 48314
Montefiore Medical center
The Bronx, New York, 10467
Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
Toledo, Ohio, 43606
Veritas Clinical Specialties LTD
Topeka, Kansas, 66606
Florida Pediatric Research Institute
Winter Park, Florida, 32789
Canada5 sites
London Health Sciences Centre
London, Ontario, N6A 5W9
CARSM Sleep Laboratory & Clinic
Montreal, Quebec, H4J 1C5
Toronto Sleep Institute
Toronto, Ontario, M4P 1P2
Toronto Psychiatric Research Foundation
Toronto, Ontario, M5K 2A7
Pediatric Sleep Research Inc.
Toronto, Ontario, M6J 3S3
Germany5 sites
Advanced Sleep Research GmbH
Berlin, 10117
Studienzentrum Wilhelmshoehe
Kassel, 34131
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, 48149
medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
Regensburg, Bavaria, 93053
Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, 19053
France3 sites
Hospital Roger Salengro
Lille, 59000
Universite Paris 5 Hôtel-Dieu
Paris, 75004
Hopital Bichat - Claude Bernard
Paris, 75018
Netherlands1 site
Sleep Wake Center SEIN Heemstede
Heemstede, North Holland, 2103 SW
About this study
Official title: A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
- Conditions
- Narcolepsy
- Being tested
- JZP-110, Placebo oral tablet
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JZP-110Drug
Placebo oral tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| 75 mg of JZP-110 | Active comparator | Once Daily Dosing Receives: Drug: JZP-110 |
| 150 mg JZP-110 | Active comparator | Once Daily Dosing Receives: Drug: JZP-110 |
| 300 mg of JZP-110 | Active comparator | Once Daily Dosing Receives: Drug: JZP-110 |
| Placebo | Placebo comparator | Once Daily Dosing Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.
Measured: Baseline to Week 12
Change in ESS Score From Baseline to Week 12
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Measured: Baseline to Week 12
Secondary outcomes (7)
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse
Measured: Baseline to Week 12
Change in Sleep Latency Time on MWT Trial 1 at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Measured: Change from baseline for sleep latency in MWT during trial 1 at week 12
Change in Sleep Latency Time on MWT Trial 2 at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Measured: Change from baseline for sleep latency in MWT during trial 2 at week 12
Change in Sleep Latency Time on MWT Trial 3 at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Measured: Change from baseline for sleep latency in MWT during trial 3 at week 12
Change in Sleep Latency Time on MWT Trial 4 at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Measured: Change from baseline for sleep latency in MWT during trial 4 at week 12
Change in Sleep Latency Time on MWT Trial 5 at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Measured: Change from baseline for sleep latency in MWT during trial 5 at week 12
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from Baseline to Week 4.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348593
- Sponsor's protocol ID
- 14-002
- Status last verified
- Jul 2019
- First submitted
- 15 Jan 2015
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rosenberg R, Thorpy MJ, Dauvilliers Y, Schweitzer PK, Zammit G, Gotfried M, Bujanover S, Scheckner B, Malhotra A. Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. J Clin Sleep Med. 2022 Jan 1;18(1):235-244. doi: 10.5664/jcsm.9550.
PubMed 34283019Rosenberg R, Baladi M, Bron M. Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Apr 1;17(4):711-717. doi: 10.5664/jcsm.9006.
PubMed 33226332Dauvilliers Y, Shapiro C, Mayer G, Lammers GJ, Emsellem H, Plazzi G, Chen D, Carter LP, Lee L, Black J, Thorpy MJ. Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. CNS Drugs. 2020 Jul;34(7):773-784. doi: 10.1007/s40263-020-00744-2.
PubMed 32588401Emsellem HA, Thorpy MJ, Lammers GJ, Shapiro CM, Mayer G, Plazzi G, Chen D, Carter LP, Villa KF, Lee L, Menno D, Black J, Dauvilliers Y. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy. Sleep Med. 2020 Mar;67:128-136. doi: 10.1016/j.sleep.2019.11.1250. Epub 2019 Dec 4.
PubMed 31926465
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy
- ClinicalTrials.gov ID
- NCT02348593
- Acronym / sponsor ID
- 14-002
- Conditions
- Narcolepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 75 mg of JZP-110 | Active comparator | Drug: JZP-110Once Daily Dosing |
| 150 mg JZP-110 | Active comparator | Drug: JZP-110Once Daily Dosing |
| 300 mg of JZP-110 | Active comparator | Drug: JZP-110Once Daily Dosing |
| Placebo | Placebo comparator | Drug: Placebo oral tabletOnce Daily Dosing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| JZP-110 | Drug | 150 mg JZP-110, 300 mg of JZP-110, 75 mg of JZP-110 |
| Placebo oral tablet | Drug | Placebo |
Primary outcome
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Time frame: Baseline to Week 12
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.
Change in ESS Score From Baseline to Week 12
Time frame: Baseline to Week 12
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
7 secondary outcomes
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Time frame: Baseline to Week 12
Change in Sleep Latency Time on MWT Trial 1 at Week 12
Time frame: Change from baseline for sleep latency in MWT during trial 1 at week 12
Change in Sleep Latency Time on MWT Trial 2 at Week 12
Time frame: Change from baseline for sleep latency in MWT during trial 2 at week 12
Change in Sleep Latency Time on MWT Trial 3 at Week 12
Time frame: Change from baseline for sleep latency in MWT during trial 3 at week 12
Change in Sleep Latency Time on MWT Trial 4 at Week 12
Time frame: Change from baseline for sleep latency in MWT during trial 4 at week 12
Change in Sleep Latency Time on MWT Trial 5 at Week 12
Time frame: Change from baseline for sleep latency in MWT during trial 5 at week 12
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4
Time frame: Baseline to Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34283019Rosenberg R, Thorpy MJ, Dauvilliers Y, Schweitzer PK, Zammit G, Gotfried M, Bujanover S, Scheckner B, Malhotra A. Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. J Clin Sleep Med. 2022 Jan 1;18(1):235-244. doi: 10.5664/jcsm.9550.
- Derived from this study: PubMed 33226332Rosenberg R, Baladi M, Bron M. Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Apr 1;17(4):711-717. doi: 10.5664/jcsm.9006.
- Derived from this study: PubMed 32588401Dauvilliers Y, Shapiro C, Mayer G, Lammers GJ, Emsellem H, Plazzi G, Chen D, Carter LP, Lee L, Black J, Thorpy MJ. Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. CNS Drugs. 2020 Jul;34(7):773-784. doi: 10.1007/s40263-020-00744-2.
- Derived from this study: PubMed 31926465Emsellem HA, Thorpy MJ, Lammers GJ, Shapiro CM, Mayer G, Plazzi G, Chen D, Carter LP, Villa KF, Lee L, Menno D, Black J, Dauvilliers Y. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy. Sleep Med. 2020 Mar;67:128-136. doi: 10.1016/j.sleep.2019.11.1250. Epub 2019 Dec 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JZP-110 in people with Narcolepsy, run by Jazz Pharmaceuticals at 60 sites in 6 countries.
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: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada, Germany, France, Finland and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02348593, which also lists 4 linked publications.
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 23 Jul 2019.