A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

Axsome Therapeutics

Status and phase: Completed; Phase 3

Conditions: ADHD

Treatments: Drug: Placebo; Drug: Solriamfetol 150 mg; Drug: Solriamfetol 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05972044

SOL-ADHD-301

Details and patient eligibility

About

FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.

Full description

Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks.

Enrollment: 516 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis of ADHD according to DSM-5 criteria.
• Provides written informed consent to participate in the study before the conduct of any study procedures.
• Male or female, aged 18 to 55 inclusive.

Exclusion criteria

• Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
• Unable to comply with study procedures.
• Medically inappropriate for study participation in the opinion of the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

516 participants in 3 patient groups, including a placebo group

Solriamfetol 150 mg

Experimental group

Description:

Up to 6 weeks

Treatment:

Drug: Solriamfetol 150 mg

Solriamfetol 300 mg

Experimental group

Description:

Up to 6 weeks

Treatment:

Drug: Solriamfetol 300 mg

Placebo

Placebo Comparator group

Description:

Up to 6 weeks

Treatment:

Drug: Placebo