An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD

An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Status

Enrolling by invitation

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07773883

Enrollment

300

Registered

2026-08-19

Start date

2026-08-06

Completion date

2027-12-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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.

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.

Interventions

DRUGSolriamfetol

Solriamfetol capsules, taken once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

Design outcomes

Primary

Measure	Time frame	Description
Treatment-Emergent Adverse Events (TEAEs)	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026