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

Primary Purpose

Attention-Deficit/Hyperactivity Disorder (ADHD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
100mg SPN-812
200mg SPN-812
300mg SPN-812
400mg SPN-812
Sponsored by
Supernus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder (ADHD)

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Florida Clinical Research Center, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

100mg SPN-812

200mg SPN-812

300mg SPN-812

400mg SPN-812

Arm Description

Placebo, qd, oral capsule

100mg SPN-812, qd, oral capsule

200mg SPN-812, qd, oral capsule

300mg SPN-812, qd, oral capsule

400mg SPN-812, qd, oral capsule

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 15, 2015
Last Updated
September 29, 2021
Sponsor
Supernus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02633527
Brief Title
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
July 25, 2016 (Actual)
Study Completion Date
July 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder (ADHD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, qd, oral capsule
Arm Title
100mg SPN-812
Arm Type
Experimental
Arm Description
100mg SPN-812, qd, oral capsule
Arm Title
200mg SPN-812
Arm Type
Experimental
Arm Description
200mg SPN-812, qd, oral capsule
Arm Title
300mg SPN-812
Arm Type
Experimental
Arm Description
300mg SPN-812, qd, oral capsule
Arm Title
400mg SPN-812
Arm Type
Experimental
Arm Description
400mg SPN-812, qd, oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Placebo was administered once daily
Intervention Type
Drug
Intervention Name(s)
100mg SPN-812
Other Intervention Name(s)
SPN-812, Low Dose
Intervention Description
100mg SPN-812 was administered once daily and compared to placebo
Intervention Type
Drug
Intervention Name(s)
200mg SPN-812
Other Intervention Name(s)
SPN-812, Low-Medium Dose
Intervention Description
200mg SPN-812 was administered once daily and compared to placebo
Intervention Type
Drug
Intervention Name(s)
300mg SPN-812
Other Intervention Name(s)
SPN-812, Medium-High Dose
Intervention Description
300mg SPN-812 was administered once daily and compared to placebo
Intervention Type
Drug
Intervention Name(s)
400mg SPN-812
Other Intervention Name(s)
SPN-812, High Dose
Intervention Description
400mg SPN-812 was administered once daily and compared to placebo
Primary Outcome Measure Information:
Title
The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)
Description
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.
Time Frame
Baseline to Week 8 (End of Study)
Secondary Outcome Measure Information:
Title
Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale
Description
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.
Time Frame
Week 8 (End of Study)
Title
Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale
Description
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.
Time Frame
Baseline to Week 8 (End of Study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph T. Hull, PhD
Organizational Affiliation
Supernus Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Florida Clinical Research Center, LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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