A Study to Assess the Efficacy and Safety of Solriamfetol in Adolescents With ADHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Solriamfetol Dose A, Solriamfetol Dose B, Placebo.
- Who it may be relevant to
- Registry conditions: ADHD. Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, 6-Week, Double-blind, Placebo- Controlled Trial of Solriamfetol in Adolescents Aged 12 to <18 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Overview
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 adolescents aged 12 to \<18 years with ADHD.
Detailed description
Eligible subjects are adolescents, 12 to \<18 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
- Drug Solriamfetol Dose A
Solriamfetol capsules, taken once daily - Drug Solriamfetol Dose B
Solriamfetol capsules, taken once daily - Drug Placebo
Placebo capsules, taken once daily
Primary outcome measures
- ADHD-RS-5 Total Score, Change from Baseline to Week 6 [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- Male or female, aged 12 to <18 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Clinical Research Site — Dothan
- Clinical Research Site — Little Rock
- Clinical Research Site — Coral Gables
- Clinical Research Site — Jacksonville
- Clinical Research Site — Maitland
- Clinical Research Site — Orlando
- Clinical Research Site — Bardstown
- Clinical Research Site — Memphis
- … and 1 more center
Identifiers
NCT: NCT07717892 · SOL-ADHD-304