Open-Label, Extension Study to 810P202

Study Overview
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Brief Summary
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Open-label, extension study for subjects that completed 810P202 to examine long term safety and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).

Official Title
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Open-Label Extension Study to Evaluate the Safety of Molindone Hydrochloride Extended-Release Tablets as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

Conditions
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Impulsive Aggression Comorbid With ADHD in Children

Intervention / Treatment
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* Drug: Molindone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successful completion of the 810P202 study. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs). Weight of at least 20kg. Able and willing to swallow tablets whole and not chewed, cut or crushed. Written informed consent/assent obtained from the subject's parent or legally-authorized representative (LAR), and written informed assent obtained from the subject if required. Exclusion Criteria: Body Mass Index (BMI) in 97th percentile or above. Clinically significant change in health status that, in the opinion of 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). Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.

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 |
| --- | --- |
| Other: Molindone<br>Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion. | Drug: Molindone<br>* The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD | Safety Assessments include: Adverse Events, clinical lab tests, vital signs, physical examinations, ECGs, Simpson-Angus Scale, Barnes Akathisia Scale, Abnormal Involuntary Movement Scale (AIMS) and Columbia Suicise Severity Rating Scale (C-SSRS) | over 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of 810M | Secondary efficacy endpoints: Retrospective-Modified Overt Aggression Scale (R-MOAS), Clinical Global Impression - Severity Scale (CGI-S), Clinical Global Impression - Improvement Scale (CGI-I), Swanson, Nolan and Pelman Rating Scale-Revised (SNAP-IV) ADHD scale scores | over 6 months |