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This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | JZP-110 and Placebo |
|
| Arm B | Experimental | JZP-110 and Placebo |
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| Arm C | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JZP-110 | Drug | 75 mg, 150 mg, 300 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation | Up to Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score | Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4). The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT) | Change from Baseline mean sleep latency (in minutes) on the MWT defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4). The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Millie Gottwald, PharmD | Jazz Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Institute For Respiratory Diseases, Inc. | Los Angeles | California | 90048 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34191352 | Derived | Videnovic A, Amara AW, Comella C, Schweitzer PK, Emsellem H, Liu K, Sterkel AL, Gottwald MD, Steinerman JR, Jochelson P, Zomorodi K, Hauser RA. Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. Mov Disord. 2021 Oct;36(10):2408-2412. doi: 10.1002/mds.28702. Epub 2021 Jun 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence A | Subjects in Treatment Sequence A were assigned the following from Period 1, Week 1 through Period 4, Week 4: Placebo, JZP-110 75 mg, JZP 110 150 mg, and JZP 110 300 mg. |
| FG001 | Treatment Sequence B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 26, 2018 | Aug 16, 2019 |
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| Other |
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| Baseline to Weeks 1, 2, 3, and 4 |
| Baseline to Weeks 1, 2, 3, and 4 |
| Pacific Research Network, Inc |
| San Diego |
| California |
| 92103 |
| United States |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | United States |
| Rocky Mountain Movement Disorders Center, PC | Englewood | Colorado | 80113 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| PAB Clinical Research | Brandon | Florida | 33511 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| QPS MRA (Miami Research Associates) | Miami | Florida | 33143 | United States |
| Bioclinica Research | Orlando | Florida | 32806 | United States |
| USF Health Byrd Institute | Tampa | Florida | 33613 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | United States |
| Center for Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| QUEST Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Clinical Neurophysiology Services, P.C. | Sterling Heights | Michigan | 48314 | United States |
| Henry Ford Medical Center - West Bloomfield | West Bloomfield | Michigan | 48322 | United States |
| St. Lukes Hospital Medical Center | Chesterfield | Missouri | 63017 | United States |
| Strong Sleep Disorders Center | Rochester | New York | 14618 | United States |
| Montefiore Sleep-Wake Disorders Center | The Bronx | New York | 10467 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Parkinson's Disease Research Unit - Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| Villages at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Evergreen Hospital Medical Center | Kirkland | Washington | 98034 | United States |
| Premier Clinical Research - Sherman | Spokane | Washington | 99202 | United States |
Subjects in Treatment Sequence B were assigned the following from Period 1, Week 1 through Period 4, Week 4: JZP-110 75 mg, JZP 110 150 mg, JZP 110 300 mg, and Placebo.
| FG002 | Treatment Sequence C | Subjects in Treatment Sequence C were assigned Placebo for each Period. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence A | Subjects in Treatment Sequence A were assigned the following from Period 1, Week 1 through Period 4, Week 4: Placebo, JZP-110 75 mg, JZP 110 150 mg, and JZP 110 300 mg. |
| BG001 | Treatment Sequence B | Subjects in Treatment Sequence B were assigned the following from Period 1, Week 1 through Period 4, Week 4: JZP-110 75 mg, JZP 110 150 mg, JZP 110 300 mg, and Placebo. |
| BG002 | Treatment Sequence C | Subjects in Treatment Sequence C were assigned Placebo for each Period. |
| BG003 | Total | Total of all reporting groups |
| 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 | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation | The Safety population includes all subjects who received at least one dose of study drug | Posted | Count of Participants | Participants | Up to Day 35 |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score | Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4). The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness. | The modified Intent-to-Treat population is defined as all randomized subjects who took at least one dose of study drug and have a Baseline and at least one post-Baseline efficacy assessment. Two subjects who did not have at least one post-baseline efficacy data were excluded from the mITT Population, resulting in a total of 64 subjects. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Weeks 1, 2, 3, and 4 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT) | Change from Baseline mean sleep latency (in minutes) on the MWT defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4). The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake. | The MWT analysis evaluated results from subjects in the mITT population who were in Group 1 only (N=53 subjects). | Posted | Least Squares Mean | Standard Error | minutes | Baseline to Weeks 1, 2, 3, and 4 |
|
Up to Day 35
The Safety population includes all subjects who received at least one dose of study drug
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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 75 mg | The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects. | 0 | 56 | 0 | 56 | 4 | 56 |
| EG001 | JZP-110 150 mg | The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects. | 0 | 55 | 0 | 55 | 5 | 55 |
| EG002 | JZP-110 300 mg | The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects. | 0 | 54 | 1 | 54 | 4 | 54 |
| EG003 | Placebo | The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects. | 0 | 64 | 0 | 64 | 0 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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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 | 2159707145 | ClinicalTrialDisclosure@JazzPharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2018 | Aug 16, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
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| Male |
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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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| OG002 | JZP-110 300mg | The JZP-110 300 mg group consisted of all subjects in the mITT population from Sequences A (28 subjects) and B (27 subjects), for a total of 55 subjects. |
| OG003 | Placebo | The Placebo group includes all subjects in the mITT population from Sequences A, B, and C - 64 subjects in total. |
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| OG003 | Placebo | The Placebo group includes all subjects in the mITT population in Group 1 from Sequences A, B, and C - 53 subjects in total. |
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