Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 Extended Release (ER)

Study Overview
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Brief Summary
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Open label, flexible dose, long-term multicenter study of safety and efficacy of SPN-812 ER in pediatric ADHD patients

Detailed Description
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This is a multicenter, open-label extension study aimed to assess long-term safety and efficacy of SPN-812 ER when administered alone or in conjunction with an Food and Drug Administration-approved Attention Deficit Hyperactivity Disorder (ADHD) medication in the treatment of ADHD in pediatric subjects who have participated in a previous blinded study of SPN-812 ER (812P202, 812P301, 812P302, 812P303, and 812P304). All pediatric subjects who complete a blinded study of SPN-812 ER will have the option to participate in this study in which all subjects will receive SPN-812 ER at an optimized dose. After an initial dose, subjects will enter an dose optimization phase of up to twelve weeks. Following optimization, subjects will return to the clinic every 3 months for up to 72 months or until the subject discontinues or the availability of SPN 812 on the market, whichever occurs first.

Official Title
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Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 ER for the Treatment of Pediatric Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)

Conditions
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Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
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* Drug: SPN-812


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completion of a previous double-blind study of SPN-812 for the treatment of ADHD. Continues to be medically healthy with clinically normal laboratory profiles, vital signs and electrocardiograms. Weight of at least 20 kg if 6-11 years old and at least 35 kg for subjects aged 12 years and up. Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); written Informed Assent/Consent obtained from the subject if appropriate. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose and throughout the study: simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration surgically sterile male partner simultaneous use of male condom and diaphragm with spermicide established hormonal contraceptive Exclusion Criteria: Current diagnosis of significant systemic disease and/or of a major psychiatric or neurological disorder, including history or family history of seizures or seizure-like disorders. History of Major Depressive Disorder is allowed if the patient is free of episodes currently and for the last six months. Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS). BMI greater than 95th percentile for the appropriate age and gender (according to the CDC BMI-for-Age Growth Charts for boys and girls). Pregnancy, breastfeeding or refusal to practice contraception during the study for FOCP. Current substance or alcohol use. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 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<br>Subjects 6-11 yrs of age will be treated with 100 to 400 mg SPN-812 ER (100 mg capsule). Subjects 12-17 yrs of age will be treated with 100 to 600 mg SPN-812 ER (100, 200 mg capsule). Subjects are given a choice to extend their participation in the study every 6 months for up to 72 months. | Drug: SPN-812<br> <br> * Other names: viloxazine extended-release;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Change from Baseline | 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or ADHD-RS-5) Score | Change from Baseline in ADHD-RS Total score by visit | ADHD-RS will be administered at baseline and every 3 months for up to 72 months | 
| Trends in Clinical Global Impression-Improvement (CGI-I) scale score | CGI-I score by visit | CGI-I will be assessed post-baseline every 3 months for up to 72 months |