NCT07773883

Brief Summary

This study is a Phase 3, multi-center, open-label trial to evaluate the long-term safety of solriamfetol in children and adolescents with ADHD.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
14mo left

Started Aug 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Aug 2026Dec 2027

Study Start

First participant enrolled

August 6, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

1.3 years

First QC Date

August 14, 2026

Last Update Submit

September 3, 2026

Conditions

ADHD

Keywords

Attention deficit hyperactivity disorderADHDSunosiSolriamfetolAxsomeNon-stimulant therapyDopamine norepinephrine reuptake inhibitorTrace amine-associated receptor 1 (TAAR1) agonist

Outcome Measures

Primary Outcomes (1)

  • Treatment-Emergent Adverse Events (TEAEs)

    An AE is defined as treatment emergent if the first onset or worsening is after the first administration of the study drug and not more than 7 days after the last dose of study drug or 30 days after the last dose of study drug for SAEs.

    Up to 52 weeks

Study Arms (1)

Solriamfetol

EXPERIMENTAL

Up to 52 weeks

Drug: Solriamfetol

Interventions

SolriamfetolDRUG

Solriamfetol capsules, taken once daily

Solriamfetol

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Completed Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3).
  • Has a parent/legal guardian to provide written informed consent and/or is willing to provide written informed assent to participate in the study.

You may not qualify if:

  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical Research Site

Dothan, Alabama, 36303, United States

Location

Clinical Research Site

Maitland, Florida, 32751, United States

Location

Clinical Research Site

Memphis, Tennessee, 38119, United States

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 19, 2026

Study Start

August 6, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)