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

NCT07717879 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2026-07-21

No results posted yet for this study

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 children aged 6 to \<12 years with ADHD.

Conditions

  • ADHD

Interventions

DRUG

Solriamfetol Dose A

Solriamfetol capsules, taken once daily

DRUG

Solriamfetol Dose B

Solriamfetol capsules, taken once daily

DRUG

Placebo

Placebo capsules, taken once daily

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-06
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07717879 on ClinicalTrials.gov