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

Completed · Phase 2 · Has a placebo group

Conditions studied: Attention-Deficit/Hyperactivity Disorder (ADHD)

In brief

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.

Key facts

Study ID

NCT02633527

Run by

Supernus Pharmaceuticals, Inc.

People needed

222

Starts

2016-02-01

Expected to finish

2016-07-25

Last updated by the study team

2021-10-27

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
• CGI-S score of at least 4
• Weight of at least 20 kg.
• Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.

You may not qualify if…

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

Where it is running

• Florida Clinical Research Center, LLC — Maitland, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.