ADHDPhase 3NCT05972044
A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
A Phase 3 study testing Solriamfetol 150 mg and Solriamfetol 300 mg in people with ADHD, run by Axsome Therapeutics, Inc. at 42 sites in United States.
Trial summary
FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ADHD
- What is being tested?
- Solriamfetol 150 mg and Solriamfetol 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 516 participants
- Where
- 42 sitesUnited States
- Study dates
- 6 Jul 2023to 14 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary diagnosis of ADHD according to DSM-5 criteria.
- Provides written informed consent to participate in the study before the conduct of any study procedures.
- Male or female, aged 18 to 55 inclusive.
Who cannot join
- Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Clinical Research Site
Austin, Texas, 78737
Clinical Research Site
Bellaire, Texas, 77401
Clinical Research Site
Berlin, New Jersey, 08009
Clinical Research Site
Boston, Massachusetts, 02131
Clinical Research Site
Cherry Hill, New Jersey, 08002
Clinical Research Site
Cincinnati, Ohio, 45219
Clinical Research Site
Clermont, Florida, 34711
Clinical Research Site
Colorado Springs, Colorado, 80910
Clinical Research Site
Dallas, Texas, 75243
Clinical Research Site
Dallas, Texas, 75251
Clinical Research Site
Doral, Florida, 33122
Clinical Research Site
Draper, Utah, 84020
Clinical Research Site
Encino, California, 91316
Clinical Research Site
Everett, Washington, 98201
Clinical Research Site
Gainesville, Florida, 32607
Clinical Research Site
Garden Grove, California, 92845
Clinical Research Site
Jacksonville, Florida, 32256
Clinical Research Site
Kettering, Ohio, 45439
Clinical Research Site
Las Vegas, Nevada, 89102
Clinical Research Site
Las Vegas, Nevada, 89128
Clinical Research Site
Lauderhill, Florida, 33319
Clinical Research Site
Lincoln, Nebraska, 68526
Clinical Research Site
Marietta, Georgia, 30060
Clinical Research Site
Media, Pennsylvania, 19063
Clinical Research Site
Memphis, Tennessee, 38119
Clinical Research Site
Miami Lakes, Florida, 33016
Clinical Research Site
Mount Kisco, New York, 10549
Clinical Research Site
New York, New York, 10128
Clinical Research Site
Newport Beach, California, 92660
Clinical Research Site
North Charleston, South Carolina, 29405
Clinical Research Site
Oklahoma City, Oklahoma, 73116
Clinical Research Site
Orlando, Florida, 32801
Clinical Research Site
Overland Park, Kansas, 66210
Clinical Research Site
Princeton, New Jersey, 08540
Clinical Research Site
Raleigh, North Carolina, 27609
Clinical Research Site
Riverside, California, 92506
Clinical Research Site
Saint Charles, Missouri, 63304
Clinical Research Site
San Antonio, Texas, 78229
Clinical Research Site
Santa Ana, California, 92705
Clinical Research Site
Sherman Oaks, California, 91403
Clinical Research Site
Torrance, California, 90504
Clinical Research Site
Walnut Creek, California, 94596
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.
FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.
Read the detailed description
Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks.
- Conditions
- ADHD
- Being tested
- Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo
- Keywords
- Attention deficit hyperactivity disorder, ADHD, Solriamfetol, Sunosi, 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 150 mgDrug
Solriamfetol tablets, taken once daily
Solriamfetol 300 mgDrug
Solriamfetol tablets, taken once daily
PlaceboDrug
Placebo tablets, taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol 150 mg | Experimental | Up to 6 weeks Receives: Drug: Solriamfetol 150 mg |
| Solriamfetol 300 mg | Experimental | Up to 6 weeks Receives: Drug: Solriamfetol 300 mg |
| 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.
Change from Baseline to Week 6 in the AISRS total score
Adult ADHD Investigator Symptom Report Scale (AISRS)
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 posted2 Aug 2023
- Study start6 Jul 2023
- Primary completion7 Feb 2025
- Study completion14 Mar 2025
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.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- 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
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972044
- Sponsor's protocol ID
- SOL-ADHD-301
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2023
- Last updated
- 10 Feb 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.
- ClinicalTrials.gov ID
- NCT05972044
- Acronym / sponsor ID
- SOL-ADHD-301
- Conditions
- ADHD
- Keywords
- Attention deficit hyperactivity disorder, ADHD, Solriamfetol, Sunosi, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 2 Aug 2023 (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.
FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.
Detailed description
Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, 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 150 mg | Experimental | Drug: Solriamfetol 150 mgUp to 6 weeks |
| Solriamfetol 300 mg | Experimental | Drug: Solriamfetol 300 mgUp to 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboUp to 6 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primary diagnosis of ADHD according to DSM-5 criteria.
- Provides written informed consent to participate in the study before the conduct of any study procedures.
- Male or female, aged 18 to 55 inclusive.
Key exclusion criteria (3 listed)
- Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
- 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 150 mgSolriamfetol tablets, taken once daily | Drug | Solriamfetol 150 mg |
| Solriamfetol 300 mgSolriamfetol tablets, taken once daily | Drug | Solriamfetol 300 mg |
| PlaceboPlacebo tablets, taken once daily | Drug | Placebo |
Primary outcome
Change from Baseline to Week 6 in the AISRS total score
Time frame: 6 weeks
Adult ADHD Investigator Symptom Report Scale (AISRS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 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 150 mg and Solriamfetol 300 mg in people with ADHD, run by Axsome Therapeutics, Inc. at 42 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 3 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: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 6 in the AISRS total score (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 10 Feb 2026.