A Study to Assess the Efficacy and Safety of Solriamfetol in Adolescents With ADHD

Purpose

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.

Condition

  • ADHD

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Solriamfetol Dose A 		Up to 6 weeks
  • Drug: Solriamfetol Dose A
    Solriamfetol capsules, taken once daily
Experimental
Solriamfetol Dose B 		Up to 6 weeks
  • Drug: Solriamfetol Dose B
    Solriamfetol capsules, taken once daily
Placebo Comparator
Placebo 		Up to weeks
  • Drug: Placebo
    Placebo capsules, taken once daily

Recruiting Locations

Clinical Research Site
Dothan, Alabama 36303

Clinical Research Site
Little Rock, Arkansas 72211

Clinical Research Site
Coral Gables, Florida 33146

Clinical Research Site
Jacksonville, Florida 32256

Clinical Research Site
Maitland, Florida 32751

Clinical Research Site
Orlando, Florida 32801

Clinical Research Site
Bardstown, Kentucky 40004

Clinical Research Site
Memphis, Tennessee 38119

Clinical Research Site
Austin, Texas 78759

More Details

Status
Recruiting
Sponsor
Axsome Therapeutics, Inc.

Study Contact

Study Director
929-618-4421
akim@axsome.com

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.