ADHD
Conditions
Keywords
Attention deficit hyperactivity disorder, ADHD, Sunosi, Solriamfetol, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor
Brief summary
This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in children aged 6 to \<12 years with ADHD.
Detailed description
Eligible subjects are children, 6 to \<12 years of age, with a primary diagnosis of ADHD based on criteria established by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol dose A, solriamfetol dose B or placebo once daily for 6 weeks.
Interventions
Solriamfetol capsules, taken once daily
Solriamfetol capsules, taken once daily
DRUGPlacebo
Placebo capsules, taken once daily
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 6 to \<12 years. * Primary diagnosis of ADHD according to DSM-5 criteria. * Has parents/legal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures.
Exclusion criteria
* Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADHD-RS-5 Total Score, Change from Baseline to Week 6 | 6 weeks | Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Child Version (ADHD-RS-5) |
Countries
United States
Contacts
CONTACTStudy Director
Outcome results
None listed