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NarcolepsyPhase 3NCT02348632

"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"

A Phase 3 study testing JZP-110 in people with Narcolepsy and Obstructive Sleep Apnea, run by Jazz Pharmaceuticals at 80 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Narcolepsy, Obstructive Sleep Apnea
What is being tested?
JZP-110
Could I receive a placebo?
No, everyone receives an active treatment
How many people
645 participants
Where
80 sitesin 6 countries
Study dates
May 2015to Dec 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:

  1. Subject meets one of the following:
  2. Completed Study 14-002 or 14-003 (Group A)
  3. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
  4. Body mass index from 18 to <45 kg/m2
  5. Consent to use a medically acceptable method of contraception
  6. Willing and able to provide written informed consent

Major Exclusion Criteria:

  1. Female subjects who are pregnant, nursing, or lactating
  2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or OSA that is associated with excessive sleepiness
  3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
  4. 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 or safety assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
  5. History of bariatric surgery within the past year or a history of roux-en-y procedure
  6. Presence or history of significant cardiovascular disease
  7. Use of any over the counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
  8. Received an investigational drug other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
  9. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products

Trial locations and contacts

80 sites in 6 countries.

80 sites in 6 countries

United States63 sites

  • Emory Sleep Center

    Atlanta, Georgia, 30329

  • NeuroTrials Research Inc.

    Atlanta, Georgia, 30342

  • FutureSearch Trials of Neurology LP

    Austin, Texas, 78731

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21224

  • Northcoast Clinical Trials Inc.

    Beachwood, Ohio, 44122

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama, 35213

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Lowcountry Lung Critical Care

    Charleston, South Carolina, 29406

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Sleep Medicine & Research center, St. Lukes Hospital

    Chesterfield, Missouri, 63017

  • The Center for Sleep & Wake Disorders

    Chevy Chase, Maryland, 20815

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Illinois at Chicago Nursing School

    Chicago, Illinois, 60612

  • Sleep Management Institute

    Cincinnati, Ohio, 45245

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45255

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Southwest Cleveland Sleep Research Center

    Cleveland, Ohio, 44130

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Missouri

    Columbia, Missouri, 65201

  • Sleep Med of South Carolina Clinical Research Solutions

    Columbia, South Carolina, 29201

  • Henry Ford Hospital Sleep Disorders & Research Center

    Detroit, Michigan, 48202

  • Ohio Sleep Medicine & Neuroscience Institute

    Dublin, Ohio, 43017

  • 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

  • UC San Diego Medical Center

    La Jolla, California, 92037

  • Critical care Pulmonary & Sleep Associates, LLC

    Lakewood, Colorado, 80228

  • Rowe Neurology Institute RNI - Lenexa

    Lenexa, Kansas, 66214

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • So Cal Institute For Respiratory Diseases, Inc.

    Los Angeles, California, 90048

  • Kentucky Research Group

    Louisville, Kentucky, 402318

  • SleepMed of Central Georgia

    Macon, Georgia, 31201

  • Advanced Neurodiagnostic Center

    Metairie, Louisiana, 70006

  • New York University Medical Center

    New York, New York, 10016

  • Clinilabs

    New York, New York, 10019

  • Neurocare, Inc.

    Newton, Massachusetts, 24590

  • EVMS Sleep Medicine

    Norfolk, Virginia, 23510

  • Pacific Sleep Medicine

    Oceanside, California, 92054

  • The Research Center of Southern California

    Oceanside, California, 92056

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • Center for Sleep and Circadian Neurobiology

    Philadelphia, Pennsylvania, 19104

  • UPMC Sleep Medicine Center

    Pittsburgh, Pennsylvania, 15213

  • 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

  • VA San Diego Healthcare System

    San Diego, California, 92161

  • Santa Monica Clinical Trials

    Santa Monica, California, 90404

  • 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

  • American Sleep Medicine

    Vienna, Virginia, 22182

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Florida Pediatric Research Institute

    Winter Park, Florida, 32789

Other trials in United States

Canada6 sites

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • CARSM Sleep Laboratory & Clinic

    Montreal, Quebec, H4J 1C5

  • Niagra Clinical Research

    Niagra Falls, Ontario, L2E 7H9

  • Toronto Sleep Institute

    Toronto, Ontario, M4P 1P2

  • Toronto Psychiatric Research Foundation

    Toronto, Ontario, m5K 2A7

  • Pediatric Sleep Research Inc

    Toronto, Ontario, M6J 3S3

Other trials in Canada

France6 sites

  • CHU de Dijon

    Dijon, 21000

  • Grenoble University Hospital

    La Tronche, 38700

  • Hospital Roger Salengro

    Lille, 59000

  • Universite Paris 5 Hôtel-Dieu

    Paris, 75004

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • CHU de Poitiers

    Poitiers, 86000

Other trials in France

Finland2 sites

  • Unesta Research Center

    Tampere, 33200

  • University of Turku , Sleep Research Centre

    Turku, 20520

Other trials in Finland

Germany2 sites

  • Somnolab Dortmund

    Dortmund, 44263

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055

Other trials in Germany

Netherlands1 site

  • Sleep Wake Center SEIN Heemstede

    Heemstede, North Holland, 2103 SW

Other trials in Netherlands

About this study

Official title: A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

Being tested
JZP-110
Medical subject headings
Narcolepsy, Sleep Apnea, Obstructive

What participants receive

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

  • JZP-110Drug

Study groups in NCT02348632
Study groupRoleWhat they receive
75 mg - 300 mg of JZP-110OtherOnce Daily Dosing
Receives: Drug: JZP-110

What is being measured

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

  1. Change in Epworth Sleepiness Scale (ESS) Score

    Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. 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. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period.

    Measured: Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)

Secondary outcomes (2)

  1. Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)

    Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.

    Measured: Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)

  2. Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)

    Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.

    Measured: Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)

Timeline

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

  1. First posted28 Jan 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2017
  4. Study completionDec 2017

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
645 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02348632
Sponsor's protocol ID
14-005
Status last verified
Jun 2019
First submitted
15 Jan 2015
Last updated
25 Jun 2019
Data monitoring committee
No

Publications

  • Malhotra A, Strollo PJ Jr, Pepin JL, Schweitzer P, Lammers GJ, Hedner J, Redline S, Chen D, Chandler P, Bujanover S, Strohl K. Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy. Sleep Med. 2022 Dec;100:165-173. doi: 10.1016/j.sleep.2022.08.005. Epub 2022 Aug 14.

    PubMed 36084494

  • Weaver TE, Pepin JL, Schwab R, Shapiro C, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Bron M, Chandler P, Lee L, Malhotra A. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Oct 1;17(10):1995-2007. doi: 10.5664/jcsm.9384.

    PubMed 34606437

  • Schweitzer PK, Strohl KP, Mayer G, Rosenberg R, Chandler P, Baladi M, Lee L, Malhotra A. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. J Clin Sleep Med. 2021 Apr 1;17(4):659-668. doi: 10.5664/jcsm.8992.

    PubMed 33179591

  • Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Chandler P, Lee L, Schwab R. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020 Feb 13;43(2):zsz220. doi: 10.1093/sleep/zsz220.

    PubMed 31691827

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JZP-110 in people with Narcolepsy and Obstructive Sleep Apnea, run by Jazz Pharmaceuticals at 80 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 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Canada, France, Finland, Germany 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. 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 25 Jun 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 Epworth Sleepiness Scale (ESS) Score (time frame: Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)). 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 NCT02348632, 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 25 Jun 2019.

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