Attention-Deficit/Hyperactivity Disorder
Conditions
Brief summary
Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients
Detailed description
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 who completed a randomized, double-blind, placebo-controlled clinical trial, including (A) a Phase 2 (Study 812P202: children 6 to 12 years of age) or a Phase 3 trial (Study 812P301 or 812P303: children 6 to 11 years of age; or Study 812P302 or 812P304: adolescents 12 to 17 years of age) or (B) a Phase 4 trial (Study 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).
Interventions
DRUGSPN-812
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.
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Cohort 'A' Inclusion/
Exclusion criteria
Inclusion Criteria 'A': 1. Completion of a previous blinded study of SPN-812 for the treatment of ADHD. 2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs). 3. Weight of at least 20 kg if 6-11 years old and at least 35 kg if 12 years or older. 4. 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. 5. 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: 1. simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration 2. surgically sterile male partner 3. simultaneous use of male condom and diaphragm with spermicide 4. established hormonal contraceptive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | up to 72 months | The incidence (percentage of subjects dosed) of adverse events by System Organ Class and Preferred term by cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV-Preschool, ADHD-RS-IV or ADHD-RS-5) Score | up to 72 months | Change from Baseline in ADHD-RS Total score by visit by cohort |
| Trends in Clinical Global Impression-Improvement (CGI-I) scale score | up to 72 months | CGI-I score by visit by cohort |
Countries
United States
Contacts
STUDY_DIRECTORJonathan Rubin, MD, MBA
Supernus Pharmaceuticals, Inc.
Outcome results
None listed