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COMPLETED Phase 3

Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)

NCT02618408 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of Impulsive Aggression (IA) in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 426 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.

Interventions

  • DRUG Placebo
  • DRUG SPN-810 (18 mg)
  • DRUG SPN-810 (36 mg)

Study Locations (20)

Florida

  • Meridien Research at Florida Clinical Research Center — Bradenton
  • Sarkis Clinical Trials — Gainesville
  • Florida Clinical Research Center, LLC. — Maitland
  • CNS Healthcare of Orlando — Orlando

California

  • ProScience — Culver City
  • Behavioral Research Specialists — Glendale
  • Neuropsychiatric Research Center of Orange County — Orange

Illinois

  • American Medical Research — Chicago
  • Capstone Clinical Research — Libertyville

Oklahoma

  • Oklahoma Clinical Research Center — Oklahoma City
  • Paradigm Research Professionals — Oklahoma City

Tennessee

  • CNS Healthcare — Memphis
  • Research Strategies of Memphis, LLC — Memphis

Arkansas

  • Woodland Research Northwest — Rogers

Kansas

  • Psychiatric Associates — Overland Park

Maryland

  • Hugo W Moser Research Institute at Kennedy Krieger — Baltimore

Trial Details

FieldValue
Enrollment Target 333 participants
Start Date 2016-01-25
Est. Completion 2019-10-24
Phase Phase 3

Sponsor

Supernus Pharmaceuticals

43 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02618408

The ClinicalTrials.gov registry entry for NCT02618408 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Supernus Pharmaceuticals, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Attention Deficit Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02618408 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02618408 about?

NCT02618408 is a clinical study titled "Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)". The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of Impulsive Aggression (IA) in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 426 subjects aged 6 to 12 years with...

What is the current status of trial NCT02618408?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 333 participants. The study started on 2016-01-25. Estimated completion is 2019-10-24.

What conditions does trial NCT02618408 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder (ADHD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02618408?

The interventions under investigation include: Placebo (DRUG), SPN-810 (18 mg) (DRUG), SPN-810 (36 mg) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02618408?

This trial is sponsored by Supernus Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02618408 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial