Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD

Supernus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Treatments: Drug: 300mg SPN-812; Drug: 400mg SPN-812; Drug: 200mg SPN-812; Drug: Placebo; Drug: 100mg SPN-812

Study type: Interventional

Funder types: Industry

Identifiers

NCT02633527

812P202

Details and patient eligibility

About

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.

Full 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).

Enrollment: 222 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
2. ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
3. CGI-S score of at least 4
4. Weight of at least 20 kg.
5. Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.

Exclusion criteria

1. Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
2. Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
3. Significant systemic disease.
4. Evidence of suicidality within the six months before Screening or at Screening.
5. BMI greater than 95th percentile for the appropriate age and gender.
6. Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
7. Substance or alcohol use during the last three months.
8. Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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222 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo, qd, oral capsule

Treatment:

Drug: Placebo

100mg SPN-812

Experimental group

Description:

100mg SPN-812, qd, oral capsule

Treatment:

Drug: 100mg SPN-812

200mg SPN-812

Experimental group

Description:

200mg SPN-812, qd, oral capsule

Treatment:

Drug: 200mg SPN-812

300mg SPN-812

Experimental group

Description:

300mg SPN-812, qd, oral capsule

Treatment:

Drug: 300mg SPN-812

400mg SPN-812

Experimental group

Description:

400mg SPN-812, qd, oral capsule

Treatment:

Drug: 400mg SPN-812