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

Conditions

• ADHD

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Solriamfetol 150 mg — DRUG
  Solriamfetol tablets, taken once daily
• Solriamfetol 300 mg — DRUG
  Solriamfetol tablets, taken once daily
• Placebo — DRUG
  Placebo tablets, taken once daily

Study Details

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.

Key Dates

Start date

Jul 6, 2023

Status verified

Feb 2026

Primary completion

Feb 7, 2025

Completion

Mar 14, 2025

Study Design

Enrollment

516 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Solriamfetol 150 mg
  Up to 6 weeks
• Experimental: Solriamfetol 300 mg
  Up to 6 weeks
• Placebo Comparator: Placebo
  Up to 6 weeks

Primary Outcome Measure

Change from Baseline to Week 6 in the AISRS total score [ Time Frame: 6 weeks ]

Locations (42)

Find similar trials in Encino, CA

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