Excessive Daytime SleepinessPhase 4SHARPNCT04789174
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
A Phase 4 study testing Solriamfetol in people with Excessive Daytime Sleepiness and Obstructive Sleep Apnea, run by Axsome Therapeutics, Inc. at 28 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Impaired Cognitive Function
- What is being tested?
- Solriamfetol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 17 May 2021to 19 Sep 2022
- Phase
- Phase 4
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Consistent number of hours of primary PAP therapy use (with downloadable history) for OSA on at least 5 nights/week for at least 1 month prior to Baseline (with or without prior OSA surgical intervention), OR
- No current use of PAP therapy for at least 1 month prior to Baseline but a history of at least 1 month of attempting to use PAP as the primary OSA therapy with at least 1 documented adjustment that was made in an attempt to optimize the therapy (with or without prior OSA surgical intervention), OR
- History of a surgical intervention intended to treat OSA symptoms (with or without current PAP use as primary OSA therapy).
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- 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:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
- Must agree to use contraception/barrier
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:
- Is a woman of nonchildbearing potential (WONCBP) OR
- Is a WOCBP and using a contraceptive method that is highly effective
- Capable of giving signed informed consent.
Who cannot join
- Female participants who are pregnant, nursing, or lactating.
- Usual bedtime later than 1 AM (0100 hours).
- Occupation requiring nighttime or variable shift work.
- Unable to understand or perform DSST test per investigator's judgement.
- Use a PAP machine with no adherence data downloadable ability.
- Diagnosis of another sleep disorder (other than OSA) including: circadian rhythm sleep disorders, narcolepsy, restless legs syndrome determined by participant sleep history.
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- Presence of acutely unstable major depression or current major depressive episode as based on the judgement of the investigator.
- Participants with active clinically significant illness, including endocrine, neoplastic, gastrointestinal, hematological, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease, and/or surgical history which could interfere with the study efficacy, safety, conduct or the ability of the participant to complete the study based on the judgement of the investigator, or place the participant at risk during the trial or compromise the study objectives.
- History or presence of any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with an impact on cognitive function.
- History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- History of bariatric surgery within the past year or a history of any gastric bypass procedure.
- Participants with movement or motor disorders such as Parkinson's disease, as they will not be able to complete the DSST.
- Presence of renal impairment or calculated creatinine clearance < 60 mL/minute.
- Clinically significant ECG abnormality in the opinion of the investigator.
- Presence of significant cardiovascular disease.
- Laboratory value(s) outside the laboratory reference range that is considered to be clinically significant by the investigator (clinical chemistry, hematology, and urinalysis). NOTE: Screening labs may be repeated once.
- Hypothyroidism or hyperthyroidism, unless stabilized by appropriate medication for at least 3 months prior to Screening (a normal thyroid-stimulating hormone is required prior to Randomization at Baseline).
- Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of EDS within a time period prior to the Baseline visit corresponding to at least 5 half-lives of the drug(s) or planned use of such drug(s) at some point throughout the duration of the 5-week double-blind treatment period.
- Current or recent (within the past 2 years) diagnosis of a moderate or severe substance use disorder (excluding caffeine) according to DSM-5 criteria, or seeking treatment for a substance-related disorder. Nicotine use disorder is excluded only if it has an effect on sleep (ie, a participant who routinely awakens at night to smoke).
- Excessive caffeine use.
- Urine drug screen positive for amphetamine, methamphetamine, tricyclic antidepressants, propoxyphene, benzodiazepines, barbiturates, cocaine, marijuana, morphine, ecstasy, oxycodone, buprenorphine, methadone, or phencyclidine at Screening or at any point throughout the duration of the study.
- History of regular heavy use of tetrahydrocannabinol (THC) is excluded. Sporadic recreational users of THC can complete a repeat urine drug screen during the Screening period. If this is negative, the participant may be allowed to enter the study pending agreement to completely refrain from the use of THC during the course of the study.
- Positive alcohol test at Screening.
- Participants who binge drink, defined as 5 or more drinks in a day for men or 4 or more drinks in a day for women at least once in past month.
- History of phenylketonuria or history of hypersensitivity to phenylalanine-derived products.
- Currently receiving MAO inhibitors or having had received MAO inhibitors for 14 days prior to the Baseline visit.
- Previous exposure to solriamfetol.
- Received an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to the Baseline visit, or plans to use an investigational drug (other than the study drug) during the study.
- Is currently participating in another clinical study.
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States15 sites
NeuroTrials Research Inc
Atlanta, Georgia, 30328
FutureSearch Trials of Neuroglogy
Austin, Texas, 78731
Sleep Medicine & Research Center
Chesterfield, Missouri, 63017
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
CTI-Clinical Research Center
Cincinnati, Ohio, 45212
Intrepid Research, LLC
Cincinnati, Ohio, 45245
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
The Neurological Center of north Georgia.
Gainesville, Georgia, 30501
Advanced Respiratory and Sleep Medicine, PLLC
Huntersville, North Carolina, 28078
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
Southern California Institute for Respiratory Disease
Los Angeles, California, 90048
Henry Ford Health System
Novi, Michigan, 48377
Sleep Therapy & Research Center
San Antonio, Texas, 78229
SDS Clinical Trials, Inc
Santa Ana, California, 92705
Sleep and Performance Research Center
Spokane, Washington, 99202
Italy4 sites
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Emilia-Romagna, 40139
IRCCS Ospedale San Raffaele - Servizio Farmacia
Milan, Lombardy, 20132
UOC Farmacia e Politiche del farmaco, edif 41
Pisa, 56126
IRCCS Associazione Oasi Maria SS Onlus
Troina, Sicily, 94018
Canada3 sites
University of Calgary
Calgary, Alberta, T2N 4N1
MedSleep Inc. o/a Toronto Sleep Institute
Toronto, Ontario, M4P 1P2
Jodha Tishon Inc
Toronto, Ontario, M5S 3A3
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital de la Santa Creu I Sant Pau
Barcelona, 08041
Instiut de Reccerca Biomedica de Lledia
Lleida, 25198
Netherlands2 sites
Amphia Hospital
Breda, 4818 CK
Sleep-Waakcentrum SEIN
Heemstede, 2104 SW
About this study
Official title: Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (SHARP): a 5-Week Double-blind, Placebo-controlled, Randomized, Crossover, Multicenter Study of Solriamfetol in Improving Cognitive Function in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Plus Impaired Cognitive Function
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.
- Being tested
- Solriamfetol, Placebo
- Keywords
- Axsome, SHARP, Solriamfetol, EDS, OSA, Cognition, Cognitive Function, DSST
- Medical subject headings
- Disorders of Excessive Somnolence, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolriamfetolDrug
Solriamfetol 75 mg/d Solriamfetol 150 mg/d
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol | Active comparator | Solriamfetol 75 mg/d Solriamfetol 150 mg/d Receives: Drug: Solriamfetol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to the end of the second double-blind treatment period (up to 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start17 May 2021
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
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 Excessive Daytime SleepinessStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789174
- Sponsor's protocol ID
- JZP110-405
- Acronym
- SHARP
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2021
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 39528111