Skip to main content
OpenTrials
Completed

NCT Number: NCT02633527

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Placebo

Drug

Placebo was administered once daily

Other names: PBO

100mg SPN-812

Drug

100mg SPN-812 was administered once daily and compared to placebo

Other names: SPN-812, Low Dose

200mg SPN-812

Drug

200mg SPN-812 was administered once daily and compared to placebo

Other names: SPN-812, Low-Medium Dose

300mg SPN-812

Drug

300mg SPN-812 was administered once daily and compared to placebo

Other names: SPN-812, Medium-High Dose

400mg SPN-812

Drug

400mg SPN-812 was administered once daily and compared to placebo

Other names: SPN-812, High Dose

Primary outcomes

  1. The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)

    Time frame: Baseline to Week 8 (End of Study)

    The Primary Endpoint was the change from baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) Total score at Week 8 (End of Study). The ADHD-RS-IV is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (<0) represent a better outcome.

Secondary outcomes

  1. Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale

    Time frame: Week 8 (End of Study)

    The first additional secondary endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 8 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". Successful therapy is indicated by a lower score (<4) in subsequent testing.

  2. Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale

    Time frame: Baseline to Week 8 (End of Study)

    The second additional secondary endpoint was the change from baseline in the Clinical Global Impression-Severity (CGI-S) Scale score at Week 8 (End of Study). The CGI-S scale is a single item clinician/investigator rating of the clinician's assessment of the severity of the ADHD symptoms in relation to the clinician's total experience with patients with ADHD. The CGI-S was rated on a 7-point Likert scale, where 1 = Normal, not at all ill, 2 = Borderline Ill, 3 = Mildly Ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, and 7 = Extremely Ill. Successful therapy is indicated by a lower CGI-S score in subsequent testing. A lower change from baseline score (<0) represents a better outcome.

Sponsors and collaborators

Lead sponsor

Supernus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Evaluation of the Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD - A Double-Blind, Placebo-Controlled, Dose-Ranging Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2015
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.