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The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solriamfetol | Active Comparator | Solriamfetol 75 mg/d Solriamfetol 150 mg/d |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solriamfetol | Drug | Solriamfetol 75 mg/d Solriamfetol 150 mg/d |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period | The DSST RBANS (Digit Symbol Substitution Test Repeatable Battery for the Assessment of Neuropsychological Status) is an objective neuropsychological test that assesses executive function, processing speed and attention. DSST RBANS scores range from a minimum of 0 (worse outcome) to a maximum of 100 (better outcome). The change from baseline was calculated as post-baseline - baseline. A positive change indicates improvement. | Baseline to the end of the second double-blind treatment period (up to 5 weeks) |
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Inclusion Criteria:
Male or female between 18 (or the legal age of consent in the jurisdiction in which the study takes place) and 65 years of age, inclusive.
Diagnosis of OSA according to International Classification of Sleep Disorders, Third Edition criteria.
Participant report (with clinician concurrence) of at least 1 of the following primary OSA therapy criteria:
Usual nightly total sleep time of ≥ 6 hours.
Body mass index from 18.5 to < 40 kg/m2.
Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 14 days after the last dose of study intervention:
• Refrain from donating sperm
PLUS, either:
A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:
Capable of giving signed informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Institute for Respiratory Disease | Los Angeles | California | 90048 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39528111 | Derived | Van Dongen HPA, Leary EB, Drake C, Bogan R, Jaeger J, Rosenberg R, Streicher C, Tabuteau H. Results of the Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-Controlled Study (SHARP): A Randomized Placebo-Controlled Double-Blind Repeated-Measures Crossover Phase IV Clinical Trial of the Effect of the Wake-Promoting Agent Solriamfetol on Cognitive Function in OSA With Excessive Daytime Sleepiness and Cognitive Impairment. Chest. 2025 Mar;167(3):863-875. doi: 10.1016/j.chest.2024.10.050. Epub 2024 Nov 9. |
| Label | URL |
|---|---|
| Axsome Therapeutics Website | View source |
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Crossover Design: Subjects meeting the entry criteria were randomized in a 1:1 ratio either to Sequence 1 (up to 150 mg solriamfetol daily for two weeks followed by placebo for two weeks) or Sequence 2 (placebo for two weeks followed by up to 150 mg solriamfetol daily for two weeks). Crossover treatment periods were separated by a 1-week washout period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Sequence 1 - Solriamfetol for two weeks followed by placebo for two weeks |
| FG001 | Sequence 2 | Sequence 2 - Placebo for two weeks followed by solriamfetol for two weeks |
| 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 | Aug 12, 2022 | Jan 9, 2026 |
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| Placebo |
| Drug |
Placebo |
|
| SDS Clinical Trials, Inc |
| Santa Ana |
| California |
| 92705 |
| United States |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32256 | United States |
| NeuroTrials Research Inc | Atlanta | Georgia | 30328 | United States |
| The Neurological Center of north Georgia. | Gainesville | Georgia | 30501 | United States |
| The Center for Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Henry Ford Health System | Novi | Michigan | 48377 | United States |
| Sleep Medicine & Research Center | Chesterfield | Missouri | 63017 | United States |
| Advanced Respiratory and Sleep Medicine, PLLC | Huntersville | North Carolina | 28078 | United States |
| CTI-Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Intrepid Research, LLC | Cincinnati | Ohio | 45245 | United States |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201 | United States |
| FutureSearch Trials of Neuroglogy | Austin | Texas | 78731 | United States |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | United States |
| Sleep and Performance Research Center | Spokane | Washington | 99202 | United States |
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada |
| MedSleep Inc. o/a Toronto Sleep Institute | Toronto | Ontario | M4P 1P2 | Canada |
| Jodha Tishon Inc | Toronto | Ontario | M5S 3A3 | Canada |
| IRCCS Istituto delle Scienze Neurologiche di Bologna | Bologna | Emilia-Romagna | 40139 | Italy |
| IRCCS Ospedale San Raffaele - Servizio Farmacia | Milan | Lombardy | 20132 | Italy |
| IRCCS Associazione Oasi Maria SS Onlus | Troina | Sicily | 94018 | Italy |
| UOC Farmacia e Politiche del farmaco, edif 41 | Pisa | 56126 | Italy |
| Amphia Hospital | Breda | 4818 CK | Netherlands |
| Sleep-Waakcentrum SEIN | Heemstede | 2104 SW | Netherlands |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu I Sant Pau | Barcelona | 08041 | Spain |
| Instiut de Reccerca Biomedica de Lledia | Lleida | 25198 | Spain |
| Royal Papworh Hospital | Cambridge | CB23 3RE | United Kingdom |
|
| Dosed With Solriamfetol |
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| Dosed With Placebo |
|
| mITT Population | mITT Population includes all subjects who received at least one dose of study drug and have at least 1 postdose evaluation of the DSST RBANS. |
|
| COMPLETED |
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| NOT COMPLETED |
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Safety Population includes all subjects who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Sequence 1 - Solriamfetol for two weeks followed by placebo for two weeks |
| BG001 | Sequence 2 | Sequence 2 - Placebo for two weeks followed by solriamfetol for two weeks |
| BG002 | 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 | Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period | The DSST RBANS (Digit Symbol Substitution Test Repeatable Battery for the Assessment of Neuropsychological Status) is an objective neuropsychological test that assesses executive function, processing speed and attention. DSST RBANS scores range from a minimum of 0 (worse outcome) to a maximum of 100 (better outcome). The change from baseline was calculated as post-baseline - baseline. A positive change indicates improvement. | mITT Population includes all subjects who received at least one dose of study drug and have at least 1 postdose evaluation of the DSST RBANS. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to the end of the second double-blind treatment period (up to 5 weeks) |
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Adverse events were collected after administration of study drug through the final visit (up to 6 weeks).
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 | Solriamfetol | Adverse events collected while subjects were in the solriamfetol period of either Sequence 1 or Sequence 2. | 0 | 59 | 0 | 59 | 6 | 59 |
| EG001 | Placebo | Adverse events collected while subjects were in the placebo period of either Sequence 1 or Sequence 2. | 0 | 59 | 0 | 59 | 1 | 59 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Dictionary | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Streicher, Vice President, Clinical Operations | Axsome Therapeutics, Inc. | 212-332-5061 | cstreicher@axsome.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2022 | Jan 22, 2026 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract 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 |
|