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

Sponsor

Axsome Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05972044

Collaborator

(none)

450

Enrollment

Locations

Arms

16.9

Anticipated Duration (Months)

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
ADHD	Drug: Solriamfetol 150 mg Drug: Solriamfetol 300 mg Drug: Placebo	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults

Actual Study Start Date :

Jul 6, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Solriamfetol 150 mg Up to 6 weeks	Drug: Solriamfetol 150 mg Solriamfetol tablets, taken once daily
Experimental: Solriamfetol 300 mg Up to 6 weeks	Drug: Solriamfetol 300 mg Solriamfetol tablets, taken once daily
Placebo Comparator: Placebo Up to 6 weeks	Drug: Placebo Placebo tablets, taken once daily

Arm

Intervention/Treatment

Experimental: Solriamfetol 150 mg

Up to 6 weeks

Drug: Solriamfetol 150 mg

Solriamfetol tablets, taken once daily

Experimental: Solriamfetol 300 mg

Up to 6 weeks

Drug: Solriamfetol 300 mg

Solriamfetol tablets, taken once daily

Placebo Comparator: Placebo

Up to 6 weeks

Drug: Placebo

Placebo tablets, taken once daily

Outcome Measures

Primary Outcome Measures

Change from Baseline to Week 6 in the AISRS total score [6 weeks]
Adult ADHD Investigator Symptom Report Scale (AISRS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Site	Orlando	Florida	United States	32801
2	Clinical Research Site	Orlando	Florida	United States	32806
3	Clinical Research Site	Cherry Hill	New Jersey	United States	08002
4	Clinical Research Site	Memphis	Tennessee	United States	38119
5	Clinical Research Site	San Antonio	Texas	United States	78229
6	Clinical Research Site	Draper	Utah	United States	84020