A Study to Assess the Efficacy and Safety of Solriamfetol in Adolescents With ADHD
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)
1 other identifier
interventional
468
1 country
9
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 adolescents aged 12 to \<18 years with ADHD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2026
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2026
CompletedFirst Submitted
Initial submission to the registry
July 16, 2026
CompletedFirst Posted
Study publicly available on registry
July 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
July 21, 2026
July 1, 2026
2 years
July 16, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ADHD-RS-5 Total Score, Change from Baseline to Week 6
Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Adolescent Version (ADHD-RS-5)
6 weeks
Study Arms (3)
Solriamfetol Dose A
EXPERIMENTALUp to 6 weeks
Solriamfetol Dose B
EXPERIMENTALUp to 6 weeks
Placebo
PLACEBO COMPARATORUp to weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Clinical Research Site
Dothan, Alabama, 36303, United States
Clinical Research Site
Little Rock, Arkansas, 72211, United States
Clinical Research Site
Coral Gables, Florida, 33146, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Maitland, Florida, 32751, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Bardstown, Kentucky, 40004, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Austin, Texas, 78759, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2026
First Posted
July 21, 2026
Study Start
June 25, 2026
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share