Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

NCT04789174 | Completed Phase 4 Results FDA Drug

• 1 other identifier: JZP110-405
• Study Type: interventional
• Target: 59
• Locations: 6 countries
• Sites: 28

Brief 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.

Conditions

Excessive Daytime Sleepiness; Obstructive Sleep Apnea; Impaired Cognitive Function

Keywords

Axsome; SHARP; Solriamfetol; EDS; OSA; Cognition; Cognitive Function; DSST

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Solriamfetol

ACTIVE COMPARATOR

Solriamfetol 75 mg/d Solriamfetol 150 mg/d

Drug: Solriamfetol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Solriamfetol DRUG

Solriamfetol 75 mg/d Solriamfetol 150 mg/d

Solriamfetol

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Axsome Therapeutics, Inc.: lead

Study Sites (28)

Southern California Institute for Respiratory Disease

Los Angeles, California, 90048, United States

Location

SDS Clinical Trials, Inc

Santa Ana, California, 92705, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32256, United States

Location

NeuroTrials Research Inc

Atlanta, Georgia, 30328, United States

Location

The Neurological Center of north Georgia.

Gainesville, Georgia, 30501, United States

Location

The Center for Sleep & Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Henry Ford Health System

Novi, Michigan, 48377, United States

Location

Sleep Medicine & Research Center

Chesterfield, Missouri, 63017, United States

Location

Advanced Respiratory and Sleep Medicine, PLLC

Huntersville, North Carolina, 28078, United States

Location

CTI-Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Intrepid Research, LLC

Cincinnati, Ohio, 45245, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

Location

FutureSearch Trials of Neuroglogy

Austin, Texas, 78731, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

Sleep and Performance Research Center

Spokane, Washington, 99202, United States

Location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MedSleep Inc. o/a Toronto Sleep Institute

Toronto, Ontario, M4P 1P2, Canada

Location

Jodha Tishon Inc

Toronto, Ontario, M5S 3A3, Canada

Location

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Emilia-Romagna, 40139, Italy

Location

IRCCS Ospedale San Raffaele - Servizio Farmacia

Milan, Lombardy, 20132, Italy

Location

IRCCS Associazione Oasi Maria SS Onlus

Troina, Sicily, 94018, Italy

Location

UOC Farmacia e Politiche del farmaco, edif 41

Pisa, 56126, Italy

Location

Amphia Hospital

Breda, 4818 CK, Netherlands

Location

Sleep-Waakcentrum SEIN

Heemstede, 2104 SW, Netherlands

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Instiut de Reccerca Biomedica de Lledia

Lleida, 25198, Spain

Location

Royal Papworh Hospital

Cambridge, CB23 3RE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39528111 DERIVED

Related Links

• Axsome Therapeutics Website

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Sleep Apnea, Obstructive

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Caroline Streicher, Vice President, Clinical Operations
• Organization: Axsome Therapeutics, Inc.

cstreicher@axsome.com

212-332-5061

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 9, 2021
• Study Start: May 17, 2021
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Locations

GB (1); CA (3); IT (4); US (15); NL (2); ES (3)