Sarkis Clinical Trials | Gainesville, FL
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Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients
Full description
This is a multicenter open-label extension study assessing long term safety and efficacy of SPN-812 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 complete a Phase 4 trial (812P401). 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 24 months).
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Inclusion criteria
Completion of a previous blinded study of SPN-812 for the treatment of ADHD.
Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
Weight of at least ≥5th percentile for age and sex if 4 to 5 years old, at least 20 kg if 6-11 years old and at least 35 kg if 12 years or older.
Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); and written Informed Assent obtained from the subject if appropriate; written informed consent obtained from the subject if he/she is 18 years old.
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, throughout the study:
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1,400 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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