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

Phase 3Enrolling By InvitationNCT07773883

Axsome Therapeutics, Inc.300 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

ADHD

Interventions

SolriamfetolDRUG

Solriamfetol capsules, taken once daily

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Clinical Research Site

Dothan, Alabama, United States

Clinical Research Site

Maitland, Florida, United States

Clinical Research Site

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 52 weeks

Data from ClinicalTrials.gov

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