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

Study Overview
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Brief Summary
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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.

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Drug: SPN-810


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. 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 LAR, and written Informed Assent obtained from the subject if appropriate. Exclusion Criteria: 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 last visit in the previous double-blind randomized study.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label treatment with SPN-810<br>Subjects aged 6-12 years will be treated with SPN-810 starting day 1 of Visit 1 of the study. The subjects will be given a choice of extending their participation in the study every 6-month period for up to 36 months. The clinician will be able to adjust the dose of SPN-810 throughout the study based on subject's response and tolerability. | Drug: SPN-810<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events will be summarized at the subject and event level. Treatment Emergent Adverse Events (TEAEs) will be summarized by severity and relationship. TEAE incidence table will be listed and summarized by group of optimized doses. |  | 36 months | 
| Clinical laboratory values will be summarized by descriptive statistics for hematology and chemistry. For quantitative laboratory parameters both actual values and change from baseline will be summarized. |  | Assessed at baseline, at the 2-month visit, every 6 months during the study, and at the end of study visit | 
| ECG results will be summarized by visit and by group of optimized doses using descriptive statistics. Tabular summaries of quantitative ECG parameters will be presented. |  | Assessed at baseline, every 3 months during the study, and at the end of study visit | 
| Vital Signs will be summarized by group of optimized doses using descriptive statistics. Both actual values and change from baseline will be presented. |  | 36 months | 
| Suicidal ideation and behavior will be assessed through Columbia Suicide Severity Rating Scale outcomes. The summary will be presented by group of optimized doses. |  | 36 months | 
| The occurrence of neurological side effects will be assessed by change in score from baseline to each of the post-baseline visit for Simpson Angus Scale, Barnes-Akathesia Scale and Abnormal Involuntary Movement Scale. |  | 36 months |