ADHDPhase 3NCT07717879
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
A Phase 3 study testing Solriamfetol Dose A and Solriamfetol Dose B in people with ADHD, run by Axsome Therapeutics, Inc. at 30 sites in United States.
Trial summary
This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in children aged 6 to <12 years with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- ADHD
- What is being tested?
- Solriamfetol Dose A and Solriamfetol Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 30 sitesUnited States
- Study dates
- 6 Jul 2026to 30 Jun 2028
- Phase
- Phase 3
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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, aged 6 to <12 years.
- Primary diagnosis of ADHD according to DSM-5 criteria.
- Has parents/legal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures.
Who cannot join
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
United States30 sites, 30 recruiting
- Recruiting
Clinical Research Site
Anaheim, California, 92805
- Recruiting
Clinical Research Site
Atlanta, Georgia, 30318
- Recruiting
Clinical Research Site
Austin, Texas, 78759
- Recruiting
Clinical Research Site
Bardstown, Kentucky, 40004
- Recruiting
Clinical Research Site
Coral Gables, Florida, 33146
- Recruiting
Clinical Research Site
Dothan, Alabama, 36303
- Recruiting
Clinical Research Site
Everett, Washington, 98201
- Recruiting
Clinical Research Site
Friendswood, Texas, 77546
- Recruiting
Clinical Research Site
Gainesville, Florida, 32607
- Recruiting
Clinical Research Site
Irvine, California, 92604
- Recruiting
Clinical Research Site
Jackson, Mississippi, 39206
- Recruiting
Clinical Research Site
Jacksonville, Florida, 32256
- Recruiting
Clinical Research Site
Las Vegas, Nevada, 89128
- Recruiting
Clinical Research Site
Little Rock, Arkansas, 72211
- Recruiting
Clinical Research Site
Long Beach, California, 90806
- Recruiting
Clinical Research Site
Maitland, Florida, 32751
- Recruiting
Clinical Research Site
Memphis, Tennessee, 38119
- Recruiting
Clinical Research Site
North Charleston, South Carolina, 29405
- Recruiting
Clinical Research Site
Orange, California, 92868
- Recruiting
Clinical Research Site
Orlando, Florida, 32801
- Recruiting
Clinical Research Site
Orlando, Florida, 32803
- Recruiting
Clinical Research Site
Owensboro, Kentucky, 42301
- Recruiting
Clinical Research Site
Petersburg, Virginia, 23805
- Recruiting
Clinical Research Site
Portland, Oregon, 97210
- Recruiting
Clinical Research Site
Provo, Utah, 84604
- Recruiting
Clinical Research Site
San Antonio, Texas, 78229
- Recruiting
Clinical Research Site
Springfield, Massachusetts, 01103
- Recruiting
Clinical Research Site
Staten Island, New York, 10314
- Recruiting
Clinical Research Site
Walnut Creek, California, 94596
- Recruiting
Clinical Research Site
Worcester, Massachusetts, 01608
About this study
Official title: A Phase 3, Randomized, 6-Week, Double-blind, Placebo-controlled Trial of Solriamfetol in Children Aged 6 to <12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in children aged 6 to <12 years with ADHD.
Read the detailed description
Eligible subjects are children, 6 to <12 years of age, with a primary diagnosis of ADHD based on criteria established by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol dose A, solriamfetol dose B or placebo once daily for 6 weeks.
- Conditions
- ADHD
- Being tested
- Solriamfetol Dose A, Solriamfetol Dose B, Placebo
- Keywords
- Attention deficit hyperactivity disorder, ADHD, Sunosi, Solriamfetol, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solriamfetol Dose ADrug
Solriamfetol capsules, taken once daily
Solriamfetol Dose BDrug
Solriamfetol capsules, taken once daily
PlaceboDrug
Placebo capsules, taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol Dose A | Experimental | Up to 6 weeks Receives: Drug: Solriamfetol Dose A |
| Solriamfetol Dose B | Experimental | Up to 6 weeks Receives: Drug: Solriamfetol Dose B |
| Placebo | Placebo comparator | Up to 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-RS-5 Total Score, Change from Baseline to Week 6
Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Child Version (ADHD-RS-5)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start6 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717879
- Sponsor's protocol ID
- SOL-ADHD-302
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No