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

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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 are invited to participate in this study. This is a Phase 3 open label extension (OLE) study with the objective of collecting 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 will be treated with SPN-810.Subjects will be given a choice to extend participation in this study every 6 months for up to 36 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supernus Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Healthy male or female subjects, who completed and converted from a satisfactory participation in the study 810P301or 810P302 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.

2. Medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).

3. Existing diagnosis of ADHD, as described by DSM-5 and confirmed by the K-SADS PL 2013 from study 810P301 or 810P302.

4. Currently receiving monotherapy treatment with FDA-approved ADHD medication (stimulants and non-stimulants).

5. Weight of at least 20 kg.

6. Written Informed Consent obtained from the subject's parent or LAR, and written Informed Assent obtained from the subject if appropriate.

Exclusion Criteria:

1. Body Mass Index (BMI) in 99th percentile or above.

2. 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.

3. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential and sexually active males).

4. Current substance or alcohol use.

5. Suicidal thoughts or behaviors confirmed at last visit in the previous double-blind randomized study.