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Taking people in United StatesPhase 3

Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)

Key facts

Who runs it
Axsome Therapeutics, Inc.
Where
Anaheim, Atlanta, Austin, Bardstown, Coral Gables, Dothan, Everett, Fairfax, Friendswood, Gainesville, Irvine, Jackson, Jacksonville, Las Vegas, Little Rock, Long Beach, Maitland, Memphis, North Charleston, Orange, Orlando, Owensboro, Petersburg, Portland, Provo, San Antonio, Springfield, Staten Island, Union City, Walnut Creek, and Worcester, United StatesSee the 31 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
468 people, planned
Started
6 Jul 2026
Expected to end
30 Jun 2028
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Solriamfetol Dose A
  • Solriamfetol Dose B
  • Placebo
Record updated
6 November 2026

Who can take part

Age
6 years to 11 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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 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 11 years old?

Where in United States

  • Anaheim, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Atlanta, GeorgiaHospital not named in the registryContact: Study DirectorTaking people
  • Austin, TexasHospital not named in the registryContact: Study DirectorTaking people
  • Bardstown, KentuckyHospital not named in the registryContact: Study DirectorTaking people
  • Coral Gables, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Dothan, AlabamaHospital not named in the registryContact: Study DirectorTaking people
  • Everett, WashingtonHospital not named in the registryContact: Study DirectorTaking people
  • Fairfax, VirginiaHospital not named in the registryContact: Study DirectorTaking people
  • Friendswood, TexasHospital not named in the registryContact: Study DirectorTaking people
  • Gainesville, GeorgiaHospital not named in the registryContact: Study DirectorTaking people
  • Irvine, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Jackson, TennesseeHospital not named in the registryContact: Study DirectorTaking people
  • Jacksonville, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Las Vegas, NevadaHospital not named in the registryContact: Study DirectorTaking people
  • Little Rock, ArkansasHospital not named in the registryContact: Study DirectorTaking people
  • Long Beach, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Maitland, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Memphis, TennesseeHospital not named in the registryContact: Study DirectorTaking people
  • North Charleston, South CarolinaHospital not named in the registryContact: Study DirectorTaking people
  • Orange, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Orlando, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Owensboro, KentuckyHospital not named in the registryContact: Study DirectorTaking people
  • Petersburg, VirginiaHospital not named in the registryContact: Study DirectorTaking people
  • Portland, OregonHospital not named in the registryContact: Study DirectorTaking people
  • Provo, UtahHospital not named in the registryContact: Study DirectorTaking people
  • San Antonio, TexasHospital not named in the registryContact: Study DirectorTaking people
  • Springfield, MassachusettsHospital not named in the registryContact: Study DirectorTaking people
  • Staten Island, New YorkHospital not named in the registryContact: Study DirectorTaking people
  • Union City, GeorgiaHospital not named in the registryContact: Study DirectorTaking people
  • Walnut Creek, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Worcester, MassachusettsHospital not named in the registryContact: Study DirectorTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Solriamfetol Dose ATreatment being tested

    Up to 6 weeks

  • Solriamfetol Dose BTreatment being tested

    Up to 6 weeks

  • PlaceboPlacebo, for comparison

    Up to 6 weeks

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Fit questions
Built from NCT07717879, who can take part
Record updated
6 November 2026