Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)

Stopped early · Phase 3

Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD)

In brief

Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study were invited to participate in this study. This was a Phase 3 open-label extension (OLE) study to collect long-term safety data on the use of SPN-810 in treating impulsive aggression in pediatric subjects with ADHD when taken in conjunction with standard ADHD treatment. After confirmation of eligibility, all subjects were treated with SPN-810. Subjects were given a choice to extend participation in this study every 6 months for up to 36 months.

Key facts

Study ID

NCT02691182

Run by

Supernus Pharmaceuticals, Inc.

People needed

491

Starts

2016-04-01

Expected to finish

2021-05-01

Last updated by the study team

2024-05-16

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Healthy male or female subjects, who completed and converted from a satisfactory participation in the study 810P301, 810P302, 810P503 and 810P204 or discontinued early from the previous study during the maintenance phase and allowed to enroll only after consultation between the Investigator, the Medical Monitor and the Sponsor.
• Medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
• Existing diagnosis of ADHD, as described by DSM-5 and confirmed by the K-SADS PL 2013 from study 810P301 or 810P302 or by the MINI-KID from study 810P503 or 810P204.
• Currently receiving monotherapy treatment with FDA-approved ADHD medication (stimulants and non-stimulants).
• Weight of at least 20 kg.
• Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR), and written Informed Assent obtained from the subject if appropriate.

You may not qualify if…

• Body Mass Index (BMI) in 99th percentile or above.
• Clinically significant change in health status, safety concern or any other reason that, in the opinion of the Sponsor or the Investigator, would prevent the subject from participating in this study or successfully completing this study.
• Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential and sexually active males).
• Current substance or alcohol use.
• Suicidal thoughts or behaviors confirmed at Visit 7 for 810P301 or 810P302, Visit 8 for 810P503 or Visit 6 for 810P204 studies.

Where it is running

• CNS Healthcare of Orlando — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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