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

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

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.

Study Overview

• Status: Completed
• Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Drug: Placebo; Drug: 100mg SPN-812; Drug: 200mg SPN-812; Drug: 300mg SPN-812; Drug: 400mg SPN-812

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).

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo, qd, oral capsule	Drug: Placebo; Placebo was administered once daily; Other Names: PBO
Experimental: 100mg SPN-812; 100mg SPN-812, qd, oral capsule	Drug: 100mg SPN-812; 100mg SPN-812 was administered once daily and compared to placebo; Other Names: SPN-812, Low Dose
Experimental: 200mg SPN-812; 200mg SPN-812, qd, oral capsule	Drug: 200mg SPN-812; 200mg SPN-812 was administered once daily and compared to placebo; Other Names: SPN-812, Low-Medium Dose
Experimental: 300mg SPN-812; 300mg SPN-812, qd, oral capsule	Drug: 300mg SPN-812; 300mg SPN-812 was administered once daily and compared to placebo; Other Names: SPN-812, Medium-High Dose
Experimental: 400mg SPN-812; 400mg SPN-812, qd, oral capsule	Drug: 400mg SPN-812; 400mg SPN-812 was administered once daily and compared to placebo; Other Names: SPN-812, High Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)	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.	Baseline to Week 8 (End of Study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale	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.	Week 8 (End of Study)
Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale	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.	Baseline to Week 8 (End of Study)

Collaborators and Investigators

• Sponsor: Supernus Pharmaceuticals, Inc.
• Investigators: Study Director: Joseph T. Hull, PhD, Supernus Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): July 25, 2016
• Study Completion (Actual): July 25, 2016

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 812P202