Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Solriamfetol Dose A
DrugSolriamfetol capsules, taken once daily
Solriamfetol Dose B
DrugSolriamfetol capsules, taken once daily
Placebo
DrugPlacebo capsules, taken once daily
Treatment groups
468 Participants
are divided into 3 treatment groupsGroup A: Solriamfetol Dose AExperimental treatment 1 intervention
Group B: Solriamfetol Dose BExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
ADHD-RS-5 Total Score, Change from Baseline to Week 6
Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Child Version (ADHD-RS-5)
Time frame
6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov