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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 75, 150, 300 mg of JZP-110 | Active Comparator | Once Daily Dosing |
|
| Placebo | Active Comparator | Once Daily Dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JZP-110 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Week 4 to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 to Week 6 |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorder Center of Alabama | Birmingham | Alabama | 35213 | United States | ||
| The Research Center of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30471270 | Derived | 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. |
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Following screening, subjects entered the Titration phase. Subjects who were titrated to an efficacious and tolerable dose in the Titration phase remained on the same dose regimen in the Stable-Dose phase. Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | JZP-110 | Start at 75 mg, titrate up to 150 or 300 mg, or down at any time. |
| FG001 | Placebo | Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2016 | Apr 19, 2019 |
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| 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. | 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. | Week 4 to Week 6 |
| Oceanside |
| California |
| 92056 |
| United States |
| SDS Clinical Trials, INC | Orange | California | 92868 | United States |
| Santa Monica Clinical Trials | Santa Monica | California | 90404 | United States |
| Critical Care Pulmonary & Sleep Associates, LLC | Lakewood | Colorado | 80228 | United States |
| PAB Clinical Research | Brandon | Florida | 33511 | United States |
| Broward Research Group, Inc. | Hollywood | Florida | 33024 | United States |
| Oviedo Medical Research, LLC | Oviedo | Florida | 32765 | United States |
| Emory Sleep Center | Atlanta | Georgia | 30329 | United States |
| Rowe Neurology Institute RNI - Lenexa | Lenexa | Kansas | 66214 | United States |
| Veritas Clinical Specialities LTD | Topeka | Kansas | 66606 | United States |
| Advanced Neurodiagnostic Ceneter | Metairie | Louisiana | 70006 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | United States |
| Brigham & Womens Hospital | Boston | Massachusetts | 02115 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Center for Sleep & Circadian Neurobiology | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Sleep Medicine Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Lowcountry Lung Critical Care | Charleston | South Carolina | 29406 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| EVMS Sleep Medicine | Norfolk | Virginia | 23510 | United States |
| American Sleep Medicine | Vienna | Virginia | 22182 | United States |
| Tampere University Hospital | Tampere | Södra Finlands Län | 33200 | Finland |
| Turku University Hospital, Sleep Clinic | Turku | Västra Finlands Län | 20520 | Finland |
| Helsinki Sleep Center | Helsinki | 00420 | Finland |
| Grenoble University Hospital | La Tronche | Auvergne-Rhône-Alpes | 38700 | France |
| CHU de Poitiers | Poitiers | Vienne | 86000 | France |
| Klinische Forschung Schwerin GmbH | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
| Somnolab Dortmund | Dortmund | North Rhine-Westphalia | 44263 | Germany |
| Department of Sleep Medicine | Gӧteborg | Västra Götaland County | SE 413 45 | Sweden |
| COMPLETED |
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| NOT COMPLETED |
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| Stable-Dose Phase |
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| Double-Blind Withdrawal Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind Withdrawal Phase |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | A total of 124 subjects were randomized into the Double-Blind Withdrawal phase of the study and comprised the Safety population for that phase. Two of these subjects were excluded. | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | A total of 124 subjects were randomized into the Double-Blind Withdrawal phase of the study and comprised the Safety population for that phase. Two of these subjects were excluded. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | minutes | Week 4 to Week 6 |
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| Primary | 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. | Posted | Least Squares Mean | Standard Error | points on a scale | Week 4 to Week 6 |
|
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| Secondary | 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. | Posted | Number | percentage of subjects | Week 4 to Week 6 |
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| Secondary | 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. | Posted | Number | percentage of subjects | Week 4 to Week 6 |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 4 to Week 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JZP-110 (Entire Study) | Across the entire study. | 0 | 174 | 0 | 174 | 58 | 174 |
| EG001 | Placebo (Randomized Withdrawal) | During the randomized withdrawal phase only. | 0 | 62 | 0 | 62 | 0 | 62 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Dry mouth | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Palpitations | Cardiac disorders |
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The sponsor can review trial results communications prior to public release and can embargo such communications for a period of at least 60 days from the time submitted to sponsor for review. If requested by sponsor, the PI will withhold publication for up to an additional 30 days. Furthermore, the first publication of study results must be a joint publication of all study sites unless a joint manuscript has not been submitted for publication within 12 months of completion of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Disclosure & Transparency | Jazz Pharmaceuticals | 2158709177 | ClinicalTrialDisclosure@JazzPharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2016 | Apr 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
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| Male |
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| JZP-110 |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| JZP-110 |
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| Participants |
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