Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients
This is a multicenter open-label extension study assessing long term safety and efficacy of SPN-812 (viloxazine extended-release capsules) in pediatric subjects with ADHD (A) who completed a Phase 2 (812P202: children 6 to 12 years of age) or one of four Phase 3 trials (812P301/812P303: children 6 to 11 years of age; 812P302/812P304: adolescents 12 to 17 years of age) or (B) who completed a Phase 4 trial (812P401: preschool-age children, 4-5 years of age). The study is divided into two phases, Optimization and Maintenance phases. Subjects in Cohort 'A' who completed a Phase 2 or Phase 3 trial followed protocol Schedule 'A' (exposure up to 72 months). Subjects in Cohort 'B' who complete the Phase 4 trial will follow Schedule 'B' (exposure up to 6 months).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,400
Cohort 'A': Children 6-11 yrs of age take 100-400mg SPN-812 once daily by mouth and adolescents 12-17 yrs of age take 100-600mg SPN-812 once daily by mouth. Pediatric subjects in Cohort 'A' are given a choice to extend their participation in the study every 6 months for up to 72 months. Cohort 'B': Pre-school-age children 4-5 yrs of age take 100mg SPN-812 once daily by mouth. Pediatric subjects in Cohort 'B' will be treated with 100 mg SPN-812 (100 mg capsule) for up to 6 months.
Woodland International Research Group
Little Rock, Arkansas, United States
Alliance for Wellness dba Alliance for Research
Long Beach, California, United States
Incidence of adverse events
The incidence (percentage of subjects dosed) of adverse events by System Organ Class and Preferred term by cohort
Time frame: up to 72 months
Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV-Preschool, ADHD-RS-IV or ADHD-RS-5) Score
Change from Baseline in ADHD-RS Total score by visit by cohort
Time frame: up to 72 months
Trends in Clinical Global Impression-Improvement (CGI-I) scale score
CGI-I score by visit by cohort
Time frame: up to 72 months
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MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States
Meridien Research at Florida Clinical Research Center
Bradenton, Florida, United States
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Hialeah, Florida, United States
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Maitland, Florida, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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