ADHD
Conditions
Keywords
Attention deficit hyperactivity disorder, ADHD, Solriamfetol, Sunosi, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor
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.
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.
Interventions
Solriamfetol tablets, taken once daily
Solriamfetol tablets, taken once daily
DRUGPlacebo
Placebo tablets, taken once daily
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Week 6 in the AISRS total score | 6 weeks | Adult ADHD Investigator Symptom Report Scale (AISRS) |
Countries
United States
Outcome results
None listed