A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 Years Old) With Attention-Deficit/Hyperactivity Disorder (ADHD)
Supernus Pharmaceuticals, Inc.
Summary
This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.
Description
This is a randomized, double-blind, placebo-controlled, multicenter, 2-arm (1:1), parallel-group, efficacy and safety/tolerability fixed-dose study of SPN-812 in preschool-age children (4 to 5 years old) with ADHD. Participants will be screened for eligibility for up to 4 weeks. Eligible participants will be treated with study medication for 6 weeks. The total duration of the study is up to 10 weeks.
Eligibility
- Age range
- 4–5 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy. 2. Subject's parent(s) or legal guardian(s)/representative(s) is (are) willing and able to provide written informed consent before completing any study related procedures. 3. Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL). 4. Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (fema…
Interventions
- Drug100mg SPN-812
100mg SPN-812 will be administered once daily and compared to Placebo
- DrugPlacebo
Placebo will be administered once daily
Locations (47)
- The Center for Clinical Trials, Inc.Saraland, Alabama
- Preferred Research Partners, Inc.Little Rock, Arkansas
- Advanced Research Center (ARC), Inc.Anaheim, California
- Sun Valley Research CenterImperial, California
- Alliance ResearchLong Beach, California
- IMMUNOe Research CentersCentennial, Colorado