Trial Outcomes & Findings for Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (NCT NCT04789174)

Last Updated: 2026-01-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

59 participants

Primary outcome timeframe

Baseline to the end of the second double-blind treatment period (up to 5 weeks)

Results posted on

2026-01-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Sequence 1 Sequence 1 - Solriamfetol for two weeks followed by placebo for two weeks	Sequence 2 Sequence 2 - Placebo for two weeks followed by solriamfetol for two weeks
Overall Study STARTED	30	29
Overall Study Dosed With Solriamfetol	30	29
Overall Study Dosed With Placebo	30	29
Overall Study mITT Population	29	29
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence 1 n=30 Participants Sequence 1 - Solriamfetol for two weeks followed by placebo for two weeks	Sequence 2 n=29 Participants Sequence 2 - Placebo for two weeks followed by solriamfetol for two weeks	Total n=59 Participants Total of all reporting groups
Age, Continuous	52.5 years STANDARD_DEVIATION 10.48 • n=25 Participants	51.9 years STANDARD_DEVIATION 11.10 • n=25 Participants	52.2 years STANDARD_DEVIATION 10.70 • n=50 Participants
Sex: Female, Male Female	10 Participants n=25 Participants	11 Participants n=25 Participants	21 Participants n=50 Participants
Sex: Female, Male Male	20 Participants n=25 Participants	18 Participants n=25 Participants	38 Participants n=50 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Asian	1 Participants n=25 Participants	2 Participants n=25 Participants	3 Participants n=50 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Black or African American	4 Participants n=25 Participants	8 Participants n=25 Participants	12 Participants n=50 Participants
Race (NIH/OMB) White	24 Participants n=25 Participants	19 Participants n=25 Participants	43 Participants n=50 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=25 Participants	0 Participants n=25 Participants	1 Participants n=50 Participants

PRIMARY outcome

Timeframe: Baseline to the end of the second double-blind treatment period (up to 5 weeks)

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.

Outcome measures

Outcome measures
Measure	Solriamfetol n=58 Participants Solriamfetol dosed daily for up to 2 weeks	Placebo n=58 Participants Placebo dosed daily for up to 2 weeks
Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period	6.49 score on a scale Standard Error 0.650	4.75 score on a scale Standard Error 0.646

Adverse Events

Solriamfetol

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Solriamfetol n=59 participants at risk Adverse events collected while subjects were in the solriamfetol period of either Sequence 1 or Sequence 2.	Placebo n=59 participants at risk Adverse events collected while subjects were in the placebo period of either Sequence 1 or Sequence 2.
Gastrointestinal disorders Nausea	6.8% 4/59 • Number of events 4 • 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.	1.7% 1/59 • Number of events 1 • 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.
Psychiatric disorders Anxiety	3.4% 2/59 • Number of events 2 • 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.	0.00% 0/59 • 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.

Additional Information

Caroline Streicher, Vice President, Clinical Operations

Axsome Therapeutics, Inc.

Phone: 212-332-5061

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place