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

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Axsome Therapeutics, Inc.
Study ID
NCT07717879
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Jul 6, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
468 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Solriamfetol Dose A
    Up to 6 weeks
  • Experimental: Solriamfetol Dose B
    Up to 6 weeks
  • Placebo Comparator: Placebo
    Up to 6 weeks

Primary Outcome Measure

ADHD-RS-5 Total Score, Change from Baseline to Week 6 [ Time Frame: 6 weeks ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Clinical Research SiteDothanAlabama36303-
Clinical Research SiteLittle RockArkansas72211-
Clinical Research SiteCoral GablesFlorida33146-
Clinical Research SiteJacksonvilleFlorida32256-
Clinical Research SiteMaitlandFlorida32751-
Clinical Research SiteOrlandoFlorida32801-
Clinical Research SiteBardstownKentucky40004-
Clinical Research SiteMemphisTennessee38119-
Clinical Research SiteAustinTexas78759-

Find similar trials in Dothan, AL

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health

Related Studies