Frontlight ResearchEarly access
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
Key facts
- Who runs it
- Axsome Therapeutics, Inc.
- Where
- Coral Gables, Dothan, Jackson, Jacksonville, Little Rock, Maitland, Memphis, North Charleston, Orlando, and Staten Island, United StatesSee the 10 sites
- Trial code
- Status
- Enrolling by invitation
- Phase
- Phase 3
- People taking part
- 300 people, planned
- Started
- 6 Aug 2026
- Expected to end
- Dec 2027
- Type of study
- Interventional
- Treatments tested
- Solriamfetol
- Record updated
- 6 November 2026
Who can take part
- Age
- 6 years to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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 take part
- Unable to comply with study procedures
- Medically inappropriate for study participation in the opinion of the investigator
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Where in United States
- Coral Gables, FloridaHospital not named in the registryEnrolling by invitation
- Dothan, AlabamaHospital not named in the registryEnrolling by invitation
- Jackson, TennesseeHospital not named in the registryEnrolling by invitation
- Jacksonville, FloridaHospital not named in the registryEnrolling by invitation
- Little Rock, ArkansasHospital not named in the registryEnrolling by invitation
- Maitland, FloridaHospital not named in the registryEnrolling by invitation
- Memphis, TennesseeHospital not named in the registryEnrolling by invitation
- North Charleston, South CarolinaHospital not named in the registryEnrolling by invitation
- Clinical Reseach SiteOrlando, United StatesEnrolling by invitation
- Staten Island, New YorkHospital not named in the registryEnrolling by invitation
About the trial
What the trial wants to find out
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.
The group in the trial
- SolriamfetolTreatment being tested
Up to 52 weeks
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
- Fit questions
- Built from NCT07773883, who can take part
- Record updated
- 6 November 2026