ADHDPhase 3NCT07717892
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
A Phase 3 study testing Solriamfetol Dose A and Solriamfetol Dose B in people with ADHD, run by Axsome Therapeutics, Inc. at 28 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 adolescents aged 12 to <18 years with ADHD. Read more about this study
- Who is it for?
- Ages 12 to 17 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
- 28 sitesUnited States
- Study dates
- 25 Jun 2026to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, aged 12 to <18 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
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
United States28 sites, 28 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
Los Angeles, California, 90015
- 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
Orlando, Florida, 32801
- Recruiting
Clinical Research Site
Owensboro, Kentucky, 42301
- Recruiting
Clinical Research Site
Petersburg, Virginia, 23805
- 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 Adolescents Aged 12 to <18 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 adolescents aged 12 to <18 years with ADHD.
Read the detailed description
Eligible subjects are adolescents, 12 to <18 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 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, Adolescent 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 start25 Jun 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
- 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
- NCT07717892
- Sponsor's protocol ID
- SOL-ADHD-304
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, 6-Week, Double-blind, Placebo- Controlled Trial of Solriamfetol in Adolescents Aged 12 to <18 Years With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT07717892
- Acronym / sponsor ID
- SOL-ADHD-304
- Conditions
- ADHD
- Keywords
- Attention deficit hyperactivity disorder, ADHD, Sunosi, Solriamfetol, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 adolescents aged 12 to <18 years with ADHD.
Detailed description
Eligible subjects are adolescents, 12 to <18 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Solriamfetol Dose A | Experimental | Drug: Solriamfetol Dose AUp to 6 weeks |
| Solriamfetol Dose B | Experimental | Drug: Solriamfetol Dose BUp to 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboUp to weeks |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female, aged 12 to <18 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.
Key exclusion criteria (2 listed)
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solriamfetol Dose ASolriamfetol capsules, taken once daily | Drug | Solriamfetol Dose A |
| Solriamfetol Dose BSolriamfetol capsules, taken once daily | Drug | Solriamfetol Dose B |
| PlaceboPlacebo capsules, taken once daily | Drug | Placebo |
Primary outcome
ADHD-RS-5 Total Score, Change from Baseline to Week 6
Time frame: 6 weeks
Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Adolescent Version (ADHD-RS-5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- FOCUS-3 Study WebsiteLink provided by the sponsor.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solriamfetol Dose A and Solriamfetol Dose B in people with ADHD, run by Axsome Therapeutics, Inc. at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (212-332-5061, sol-adhd-304@axsome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD-RS-5 Total Score, Change from Baseline to Week 6 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.