ADHDPhase 3NCT07773883
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
A Phase 3 study testing Solriamfetol in people with ADHD, run by Axsome Therapeutics, Inc. at 7 sites in United States.
Trial summary
This study is a Phase 3, multi-center, open-label trial to evaluate the long-term safety of solriamfetol in children and adolescents with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- ADHD
- What is being tested?
- Solriamfetol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Aug 2026to Dec 2027
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Completed Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3).
- Has a parent/legal guardian to provide written informed consent and/or is willing to provide written informed assent to participate in the study.
Who cannot join
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Clinical Research Site
Dothan, Alabama, 36303
Clinical Research Site
Jacksonville, Florida, 32256
Clinical Research Site
Little Rock, Arkansas, 72211
Clinical Research Site
Maitland, Florida, 32751
Clinical Research Site
Memphis, Tennessee, 38119
Clinical Research Site
North Charleston, South Carolina, 29405
Clinical Research Site
Orlando, Florida, 32801
About this study
Official title: An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
This study is a Phase 3, multi-center, open-label trial to evaluate the long-term safety of solriamfetol in children and adolescents with ADHD.
Read the detailed description
Eligible subjects are children and adolescents with ADHD who have completed either Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3). Subjects will be assigned to age-based cohorts and will receive solriamfetol once daily for up to 52 weeks.
- Conditions
- ADHD
- Being tested
- Solriamfetol
- Keywords
- Attention deficit hyperactivity disorder, ADHD, Sunosi, Solriamfetol, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Trace amine-associated receptor 1 (TAAR1) agonist
- 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.
SolriamfetolDrug
Solriamfetol capsules, taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol | Experimental | Up to 52 weeks Receives: Drug: Solriamfetol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Events (TEAEs)
An AE is defined as treatment emergent if the first onset or worsening is after the first administration of the study drug and not more than 7 days after the last dose of study drug or 30 days after the last dose of study drug for SAEs.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start6 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT07773883
- Sponsor's protocol ID
- SOL-ADHD-303
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 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
- An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT07773883
- Acronym / sponsor ID
- SOL-ADHD-303
- Conditions
- ADHD
- Keywords
- Attention deficit hyperactivity disorder, ADHD, Sunosi, Solriamfetol, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Trace amine-associated receptor 1 (TAAR1) agonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Aug 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, open-label trial to evaluate the long-term safety of solriamfetol in children and adolescents with ADHD.
Detailed description
Eligible subjects are children and adolescents with ADHD who have completed either Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3). Subjects will be assigned to age-based cohorts and will receive solriamfetol once daily for up to 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solriamfetol | Experimental | Drug: SolriamfetolUp to 52 weeks |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Completed Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3).
- Has a parent/legal guardian to provide written informed consent and/or is willing to provide written informed assent to participate in the study.
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 |
|---|---|---|
| SolriamfetolSolriamfetol capsules, taken once daily | Drug | Solriamfetol |
Primary outcome
Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 52 weeks
An AE is defined as treatment emergent if the first onset or worsening is after the first administration of the study drug and not more than 7 days after the last dose of study drug or 30 days after the last dose of study drug for SAEs.
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.
- SOL-ADHD-302 (FOCUS-2) \& SOL-ADHD-304 (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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 in people with ADHD, run by Axsome Therapeutics, Inc. at 7 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 2 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: enrolling by invitation, 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 7 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. 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?
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?
Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 52 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; AzTrials last refreshed its copy on 26 Oct 2026.