Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 222
Healthy volunteers: no

Brief summary:
This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.

Detailed description:
This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).

Arms:
arm 1: Placebo, qd, oral capsule arm 2: 100mg SPN-812, qd, oral capsule arm 3: 200mg SPN-812, qd, oral capsule arm 4: 300mg SPN-812, qd, oral capsule arm 5: 400mg SPN-812, qd, oral capsule

Interventions: intervention 1: Placebo intervention 2: 100mg SPN-812 intervention 3: 200mg SPN-812 intervention 4: 300mg SPN-812 intervention 5: 400mg SPN-812
Intervention descriptions: intervention 1: Placebo was administered once daily intervention 2: 100mg SPN-812 was administered once daily and compared to placebo intervention 3: 200mg SPN-812 was administered once daily and compared to placebo intervention 4: 300mg SPN-812 was administered once daily and compared to placebo intervention 5: 400mg SPN-812 was administered once daily and compared to placebo

Protocol document: