Obstructive Sleep ApneaPhase 3OSANCT02348619
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
A Phase 3 study testing JZP-110 in people with Obstructive Sleep Apnea, run by Jazz Pharmaceuticals at 30 sites in 5 countries.
Trial summary
This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- JZP-110
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 30 sitesin 5 countries
- Study dates
- May 2015to Nov 2016
- 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:
- Male or female between 18 and 75 years of age, inclusive
- Diagnosis of OSA according to ICSD-3 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.
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA 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 or safety assessments or the ability of the subject to complete the trial per the judgment of the principal investigator
- History of bariatric surgery within the past year or a history of any gastric 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
- Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
- Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
- History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
United States22 sites
Emory Sleep Center
Atlanta, Georgia, 30329
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Sleep Disorder Center of Alabama
Birmingham, Alabama, 35213
Brigham & Womens Hospital
Boston, Massachusetts, 02115
PAB Clinical Research
Brandon, Florida, 33511
Lowcountry Lung Critical Care
Charleston, South Carolina, 29406
Medical University of South Carolina
Charleston, South Carolina, 29425
Duke University Medical Center
Durham, North Carolina, 27710
Broward Research Group, Inc.
Hollywood, Florida, 33024
Critical Care Pulmonary & Sleep Associates, LLC
Lakewood, Colorado, 80228
Rowe Neurology Institute RNI - Lenexa
Lenexa, Kansas, 66214
Advanced Neurodiagnostic Ceneter
Metairie, Louisiana, 70006
EVMS Sleep Medicine
Norfolk, Virginia, 23510
The Research Center of Southern California
Oceanside, California, 92056
SDS Clinical Trials, INC
Orange, California, 92868
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
Center for Sleep & Circadian Neurobiology
Philadelphia, Pennsylvania, 19104
UPMC Sleep Medicine Center
Pittsburgh, Pennsylvania, 15213
Santa Monica Clinical Trials
Santa Monica, California, 90404
Veritas Clinical Specialities LTD
Topeka, Kansas, 66606
American Sleep Medicine
Vienna, Virginia, 22182
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Finland3 sites
Helsinki Sleep Center
Helsinki, 00420
Tampere University Hospital
Tampere, Södra Finlands Län, 33200
Turku University Hospital, Sleep Clinic
Turku, Västra Finlands Län, 20520
France2 sites
Grenoble University Hospital
La Tronche, Auvergne-Rhône-Alpes, 38700
CHU de Poitiers
Poitiers, Vienne, 86000
Germany2 sites
Somnolab Dortmund
Dortmund, North Rhine-Westphalia, 44263
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, 19055
Sweden1 site
Department of Sleep Medicine
Gӧteborg, Västra Götaland County, SE 413 45
About this study
Official title: A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, 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 Obstructive Sleep Apnea (OSA)
This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- JZP-110
- Medical subject headings
- 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 group | Role | What they receive |
|---|---|---|
| 75, 150, 300 mg of JZP-110 | Active comparator | Once Daily Dosing Receives: Drug: JZP-110 |
| Placebo | Active comparator | Once Daily Dosing Receives: Drug: JZP-110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Maintenance of Wakefulness Test (MWT)
Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements.
Measured: Week 4 to Week 6
Change in the Epworth Sleepiness Scale (ESS)
Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. 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 week 4 to week 6.
Measured: Week 4 to Week 6
Secondary outcomes (3)
Patient Global Impression of Change (PGIc)
Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase. 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: Week 4 to Week 6
Clinical Global Impression of Change (CGIc)
Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Measured: Week 4 to Week 6
Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase. Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10) is a 10-item disease-specific quality of life questionnaire to assess the effect of excessiveness sleepiness on multiple activities of everyday living. The FOSQ-10 consists of 10 questions, each scored on a scale from 1-4. The questionnaire has a 4-point response format for each question (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, and 4 = no difficulty). The total score is derived by the mean of the 5 subscale scores, multiplied by 5, resulting in a possible range of scores between 5 to 20; lower FOSQ-10 scores are worse, indicating more difficulty carrying out activities; higher FOSQ-10 scores are better, indicating less difficulty carrying out activities.
Measured: Week 4 to Week 6
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 completionNov 2016
- Study completionNov 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- 174 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
- NCT02348619
- Sponsor's protocol ID
- 14-004
- Acronym
- OSA
- Status last verified
- Sep 2019
- First submitted
- 15 Jan 2015
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Strollo PJ Jr, Hedner J, Collop N, Lorch DG Jr, Chen D, Carter LP, Lu Y, Lee L, Black J, Pepin JL, Redline S; Tones 4 Study Investigators. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. Chest. 2019 Feb;155(2):364-374. doi: 10.1016/j.chest.2018.11.005. Epub 2018 Nov 22.
PubMed 30471270
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, 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 Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT02348619
- Acronym / sponsor ID
- OSA / 14-004
- Conditions
- Obstructive Sleep Apnea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Posted 9 Sep 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 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 75, 150, 300 mg of JZP-110 | Active comparator | Drug: JZP-110Once Daily Dosing |
| Placebo | Active comparator | Drug: JZP-110Once 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 | 75, 150, 300 mg of JZP-110, Placebo |
Primary outcome
Change in the Maintenance of Wakefulness Test (MWT)
Time frame: Week 4 to Week 6
Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements.
Change in the Epworth Sleepiness Scale (ESS)
Time frame: Week 4 to Week 6
Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. 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 week 4 to week 6.
3 secondary outcomes
Patient Global Impression of Change (PGIc)
Time frame: Week 4 to Week 6
Clinical Global Impression of Change (CGIc)
Time frame: Week 4 to Week 6
Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Time frame: Week 4 to Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30471270Strollo PJ Jr, Hedner J, Collop N, Lorch DG Jr, Chen D, Carter LP, Lu Y, Lee L, Black J, Pepin JL, Redline S; Tones 4 Study Investigators. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. Chest. 2019 Feb;155(2):364-374. doi: 10.1016/j.chest.2018.11.005. Epub 2018 Nov 22.
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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.
30 sites in 5 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 Obstructive Sleep Apnea, run by Jazz Pharmaceuticals at 30 sites in 5 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 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Finland, France, Germany, Sweden. 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 9 Sep 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 the Maintenance of Wakefulness Test (MWT) (time frame: Week 4 to Week 6). 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 NCT02348619, which also lists 1 linked publication.
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 9 Sep 2019.