Terminated PHASE3 INTERVENTIONAL 2-arm NCT03597503

Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment

Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment

Sponsor: Supernus Pharmaceuticals, Inc.

Conditions Attention Deficit Hyperactivity Disorder

Interventions Placebo SPN-810

Updated 12 times since 2018 Last updated: Apr 18, 2024 Started: Jul 31, 2018 Primary completion: Jan 22, 2020 Completion: Jan 22, 2020

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Business decision, not related to safety

Listed as NCT03597503, this PHASE3 trial focuses on Attention Deficit Hyperactivity Disorder and remains terminated or withdrawn. Sponsored by Supernus Pharmaceuticals, Inc., it has been updated 12 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

This study was an addition to the pediatric studies (CHIME 1 and CHIME 2) to assess the efficacy and safety of SPN-810 in the improvement of impulsive aggression (IA) behaviors in adolescents with ADHD. SPN-810 was administered in patients diagnosed with ADHD and associated features of IA, who were currently treated with an FDA-approved standard ADHD treatment and displayed persistent IA behaviors. The frequency of impulsive aggressive behaviors was assessed as a primary outcome. .

SPN-810 was administered in patients diagnosed with ADHD and associated features of IA, who were currently treated with an FDA-approved standard ADHD treatment and displayed persistent IA behaviors. The frequency of impulsive aggressive behaviors was assessed as a primary outcome.

Status Flow

Change History

12 versions recorded

Jan 2026 — Present [monthly]

Terminated PHASE3
Sep 2025 — Present [monthly]

Terminated PHASE3
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
May 2024 — Jul 2024 [monthly]

Terminated PHASE3

▶ Show 7 earlier versions

Mar 2024 — May 2024 [monthly]

Terminated PHASE3
Jan 2021 — Mar 2024 [monthly]

Terminated PHASE3
Nov 2020 — Jan 2021 [monthly]

Terminated PHASE3

Status: Recruiting → Terminated
Dec 2019 — Nov 2020 [monthly]

Recruiting PHASE3
Apr 2019 — Dec 2019 [monthly]

Recruiting PHASE3
Sep 2018 — Apr 2019 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Aug 2018 — Sep 2018 [monthly]

Not Yet Recruiting PHASE3

First recorded

Jul 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Supernus Pharmaceuticals, Inc.

Data source: Supernus Pharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Arlington, United States , Atlanta, United States , Austin, United States , Baltimore, United States , Beaumont, United States , Berlin, United States , Cincinnati, United States , Clinton, United States , Colorado Springs, United States , Columbus, United States and 26 more locations