NCT04839562

A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults

Completed Phase 2, PHASE3 Results posted Last updated 4 March 2024

What this trial tests

Phase 2, PHASE3 trial testing Solriamfetol 75 MG in Attention Deficit Hyperactivity Disorder in 66 participants. Completed in 27 January 2023.

Timeline

6 August 2021

Primary endpoint
27 January 2023

27 January 2023

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	66
Start date	6 August 2021
Primary completion	27 January 2023
Estimated completion	27 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Solriamfetol 75 MG — full drug profile →
• Solriamfetol 150 MG
• Placebo

Conditions studied

• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 65, any sex, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score Primary · six weeks

Difference between active and placebo for change in Adult ADHD Investigator Symptom Rating total score from baseline to week 6 visit. The minimum score on this scale is 0, the maximum score for the scale is 54 points.Higher numbers indicate more ADHD symptoms, lower scores reflect lower ADHD symptoms.

Group	Value	95% CI
Solriamfetol	-7.6	-9.9 – -5.3
Placebo	-2.1	-4.4 – 0.2

A Priori Definition of Clinical Improvement Primary · six weeks

25% reduction in ADHD symptoms as measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS), and a Clinical Global Impression Improvement score of 2 (much) or 1 (very much) improved. The minimum score on the AISRS scale is 0, the maximum score for the scale is 54 points.Higher numbers indicate more ADHD symptoms, lower scores reflect lower ADHD symptoms. The Clinical Global Impression (CGI) Improvement scores range from 0 to 7, with 0=not assessed,1=very much improved), 2=much improved, through to 7=very much worse. Lower scores therefore mean better outcomes.

Group	Value	95% CI
Solriamfetol	13
Placebo	2

Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Global Executive Composite Index Secondary · 6 weeks

We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. Ther are 9 subscales that are indexed under two categories, Behavioral Regulation (BRI) and Metacognition (MI), and these indexes form the overall summary score, the Global Executive Composite (GEC). Raw scores f

Group	Value	95% CI
Solriamfetol	20
Placebo	10

Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Behavioral Regulation Index Secondary · 6 weeks

We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores. The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales that are indexed under two categories, one of which is Behavioral Regulation (BRI). The raw score of the BRI is converted into a T scores (M = 50, SD = 10) are used to int

Group	Value	95% CI
Solriamfetol	18
Placebo	11

Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Metacognition Index Secondary · 6 weeks

We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales that are indexed under two categories, one of which is Metacognition Index (MI). The raw score of the MI is converted into a T scores (M = 50, SD = 10) are used to interp

Group	Value	95% CI
Solriamfetol	19
Placebo	10

Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Inhibit Subscale Secondary · 6 weeks

We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Inhibit subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive funct

Group	Value	95% CI
Solriamfetol	11
Placebo	10

Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Shift Subscale Secondary · 6 weeks

We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. Ther are 9 subscales that are indexed under two categories, one of which is the Shift subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the in

Group	Value	95% CI
Solriamfetol	20
Placebo	10

Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Emotional Control Subscale Secondary · 6 weeks

We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Emotional Control subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of execu

Group	Value	95% CI
Solriamfetol	16
Placebo	10

Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Self-Monitor Subscale Secondary · 6 weeks

We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Self-Monitor subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive

Group	Value	95% CI
Solriamfetol	13
Placebo	9

Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Initiate Subscale Secondary · 6 weeks

We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Initiate subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive func

Group	Value	95% CI
Solriamfetol	18
Placebo	9

Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Working Memory Subscale Secondary · 6 weeks

We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores) The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Working Memory subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive

Group	Value	95% CI
Solriamfetol	17
Placebo	9

Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Plan/Organize Subscale Secondary · 6 weeks

We secondarily will explore whether there are reduced symptoms of executive dysfunction (defined by a 0.5 standard deviation improvement on the Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) self-report total (GEC) or subscale scores). The BRIEF has 75 items that are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The range of scores is 0 to 225. There are 9 subscales, one of which is the Plan/Organize subscale. Raw scores for this scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive

Group	Value	95% CI
Solriamfetol	19
Placebo	11

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to endpoint (6 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Solriamfetol

Serious: 0/29 (0%)

Deaths: 0/29

Placebo

Serious: 0/31 (0%)

Deaths: 0/31

Other adverse events (19 terms — click to expand)

Reaction	System	Solriamfetol	Placebo
Cold/Infection/Allergy	Infections and infestations	—	—
Headache	General disorders	—	—
Insomnia	General disorders	—	—
Nausea/Vomiting/Diarrhea (Gastrointestinal)	Gastrointestinal disorders	—	—
Musculoskeletal	Musculoskeletal and connective tissue disorders	—	—
Decreased Appetite	Metabolism and nutrition disorders	—	—
Cardiovascular	Cardiac disorders	—	—
Increased Energy	General disorders	—	—
Mucosal Dryness	Gastrointestinal disorders	—	—
Neurological	Nervous system disorders	—	—
Dermtological	Skin and subcutaneous tissue disorders	—	—
Sedation	General disorders	—	—
Agitated/irritable	General disorders	—	—
Genitourinary	Renal and urinary disorders	—	—
Other	General disorders	—	—
Increased Appetite	Metabolism and nutrition disorders	—	—
Tense/jittery	General disorders	—	—
Anxious/Worried	Psychiatric disorders	—	—
Dizzy/Lightheaded	General disorders	—	—

Data from ClinicalTrials.gov NCT04839562 adverse events section.

Sponsor's own description

A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with diagnosis of Attention Deficit Hyperactivity Disorder.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Solriamfetol for Attention-Deficit/Hyperactivity Disorder in Adults: A Double-Blind Placebo-Controlled Pilot Study.
   Surman CBH, Walsh DM, Horick N, DiSalvo M, et al · · 2023 · cited 13× · PMID 37819836 · DOI 10.4088/jcp.23m14934
2. New frontiers in pharmacological treatment of attention-deficit hyperactivity disorder.
   Noah AA, Sedky HE. · · 2025 · PMID 40478337 · DOI 10.1007/s00210-025-04328-z