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

NCT07717892

RecruitingPhase 3

Sponsor: Axsome Therapeutics, Inc.

Conditions: ADHD

Interventions: Solriamfetol Dose A, Solriamfetol Dose B, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (9)
  • Dothan, Alabama, United States
  • Little Rock, Arkansas, United States
  • Coral Gables, Florida, United States
  • Jacksonville, Florida, United States
  • Maitland, Florida, United States
  • Orlando, Florida, United States
  • Bardstown, Kentucky, United States
  • Memphis, Tennessee, United States
  • Austin, Texas, United States