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Phase 4 N=59 Randomized Double-blind Treatment

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

Excessive Daytime Sleepiness · Obstructive Sleep Apnea · Impaired Cognitive Function

Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period — 6.49; 4.75 score on a scale — p=0.009

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Solriamfetol (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Axsome Therapeutics, Inc.
Primary completion
Sep 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period
6.49; 4.75 0.009 sig

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.

Eligibility Criteria

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:
  • 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
  • Is a WOCBP and using a contraceptive method that is highly effective
  • Capable of giving signed informed consent.

Exclusion Criteria

  • 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.
  • Laboratory value(s) outside the laboratory reference range that is considered to be clinically significant by the investigator (clinical chemistry, hematol
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04789174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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