A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHD
ConditionADHD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-11
SponsorAxsome Therapeutics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Unable to comply with study procedures.
Medically inappropriate for study participation in the opinion of the investigator.
Trial design
Treatments tested in this trial
- Solriamfetol Dose A
- Solriamfetol Dose B
- Placebo
Treatment groups
468 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov