Clinical Trials Logo
  1. Home
  2. ADHD
  3. NCT05972044
  4. Details
NCT05972044 Clinical Trial

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

ADHD Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05972044
Other study ID # SOL-ADHD-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 6, 2023
Est. completion date December 2024

Study information
Verified date April 2024
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone 212-332-5061
Email cstreicher@axsome.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 450
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
• Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
• Placebo
Placebo tablets, taken once daily

Locations
Country Name City State
United States Clinical Research Site Alpharetta Georgia
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Austin Texas
United States Clinical Research Site Bellaire Texas
United States Clinical Research Site Berlin New Jersey
United States Clinical Research Site Boston Massachusetts
United States Clinical Research Site Cherry Hill New Jersey
United States Clinical Research Site Cincinnati Ohio
United States Clinical Research Site Colorado Springs Colorado
United States Clinical Research Site Dallas Texas
United States Clinical Research Site Dallas Texas
United States Clinical Research Site Draper Utah
United States Clinical Research Site Encino California
United States Clinical Research Site Everett Washington
United States Clinical Research Site Gainesville Florida
United States Clinical Research Site Garden Grove California
United States Clinical Research Site Hickory North Carolina
United States Clinical Research Site Jacksonville Florida
United States Clinical Research Site Kettering Ohio
United States Clinical Research Site Lafayette California
United States Clinical Research Site Las Vegas Nevada
United States Clinical Research Site Las Vegas Nevada
United States Clinical Research Site Marietta Georgia
United States Clinical Research Site Media Pennsylvania
United States Clinical Research Site Memphis Tennessee
United States Clinical Research Site Miami Lakes Florida
United States Clinical Research Site Mount Kisco New York
United States Clinical Research Site New York New York
United States Clinical Research Site North Charleston South Carolina
United States Clinical Research Site Oklahoma City Oklahoma
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Overland Park Kansas
United States Clinical Research Site Palm Bay Florida
United States Clinical Research Site Raleigh North Carolina
United States Clinical Research Site Riverside California
United States Clinical Research Site Saint Charles Missouri
United States Clinical Research Site San Antonio Texas
United States Clinical Research Site Santa Ana California
United States Clinical Research Site Sherman Oaks California
United States Clinical Research Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline to Week 6 in the AISRS total score Adult ADHD Investigator Symptom Report Scale (AISRS) 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT03148782 - Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase N/A
Recruiting NCT06038942 - Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress N/A
Not yet recruiting NCT06456372 - Digital Health Intervention for Children With ADHD N/A
Completed NCT05518435 - Managing Young People With ADHD in Primary Care Study
Active, not recruiting NCT04978792 - Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD? N/A
Completed NCT03216512 - Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD N/A
Completed NCT02829528 - Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention N/A
Completed NCT02900144 - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) N/A
Not yet recruiting NCT02906501 - Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances N/A
Terminated NCT02271880 - Improving Medication Adherence in ADHD Adolescents N/A
Completed NCT02562469 - ACTIVATE: A Computerized Training Program for Children With ADHD N/A
Recruiting NCT02255565 - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study Phase 4
Completed NCT02463396 - Mindfulness Training in Adults With ADHD N/A
Terminated NCT01733680 - Amiloride Hydrochloride as an Effective Treatment for ADHD Early Phase 1
Completed NCT01673594 - Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist Phase 4
Completed NCT02300597 - Internet-based Support for Young People With ADHD and Autism - a Controlled Study N/A
Active, not recruiting NCT01137318 - Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT01404273 - Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder N/A
Completed NCT00586157 - Study of Medication Patch to Treat Children Ages 6-12 With ADHD Phase 4
Completed NCT00573859 - The Reinforcing Mechanisms of Smoking in Adult ADHD Phase 1/Phase 2

External Links