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

NCT05972044 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2026-02-10

No results posted yet for this study

Summary

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.

Conditions

  • ADHD

Interventions

DRUG

Solriamfetol 150 mg

Solriamfetol tablets, taken once daily

DRUG

Solriamfetol 300 mg

Solriamfetol tablets, taken once daily

DRUG

Placebo

Placebo tablets, taken once daily

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2025-02-07
Completion
2025-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05972044 on ClinicalTrials.gov