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Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 Extended Release (ER)

Primary Purpose

Attention-Deficit/Hyperactivity Disorder

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
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

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Completion of a previous double-blind study of SPN-812 for the treatment of ADHD.
  2. Continues to be medically healthy with clinically normal laboratory profiles, vital signs and electrocardiograms.
  3. Weight of at least 20 kg if 6-11 years old and at least 35 kg for subjects aged 12 years and up.
  4. Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); written Informed Assent/Consent obtained from the subject if appropriate.

  5. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose and throughout the study:

    1. simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration
    2. surgically sterile male partner
    3. simultaneous use of male condom and diaphragm with spermicide
    4. established hormonal contraceptive

Exclusion Criteria:

  1. Current diagnosis of significant systemic disease and/or of a major psychiatric or neurological disorder, including history or family history of seizures or seizure-like disorders. History of Major Depressive Disorder is allowed if the patient is free of episodes currently and for the last six months.
  2. Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS).
  3. BMI greater than 95th percentile for the appropriate age and gender (according to the CDC BMI-for-Age Growth Charts for boys and girls).
  4. Pregnancy, breastfeeding or refusal to practice contraception during the study for FOCP.
  5. Current substance or alcohol use.
  6. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Sites / Locations

  • Woodland International Research Group
  • Alliance for Wellness dba Alliance for Research
  • MCB Clinical Research Centers, LLC
  • Meridien Research at Florida Clinical Research Center
  • Sarkis Clinical Trials
  • Indago Research & Health Center, Inc.
  • Florida Clinical Research Center, LLC.
  • Florida Clinical Research Center, LLC
  • IPS Research
  • Paradigm Research Professionals
  • Clinical Neuroscience Solutions, Inc.
  • CNS Healthcare
  • Bayou City Research Corporation
  • Road Runner Research
  • Ericksen Research & Development
  • Northwest Clinical Trials

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-Label Treatment

Arm Description

Subjects 6-11 yrs of age will be treated with 100 to 400 mg SPN-812 ER (100 mg capsule). Subjects 12-17 yrs of age will be treated with 100 to 600 mg SPN-812 ER (100, 200 mg capsule). Subjects are given a choice to extend their participation in the study every 6 months for up to 72 months.

Outcomes

Primary Outcome Measures

Incidence of adverse events
Change from Baseline

Secondary Outcome Measures

Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or ADHD-RS-5) Score
Change from Baseline in ADHD-RS Total score by visit
Trends in Clinical Global Impression-Improvement (CGI-I) scale score
CGI-I score by visit

Full Information

First Posted
April 4, 2016
Last Updated
April 13, 2023
Sponsor
Supernus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02736656
Brief Title
Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 Extended Release (ER)
Official Title
Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 ER for the Treatment of Pediatric Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2016 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Open label, flexible dose, long-term multicenter study of safety and efficacy of SPN-812 ER in pediatric ADHD patients
Detailed Description
This is a multicenter, open-label extension study aimed to assess long-term safety and efficacy of SPN-812 ER when administered alone or in conjunction with an Food and Drug Administration-approved Attention Deficit Hyperactivity Disorder (ADHD) medication in the treatment of ADHD in pediatric subjects who have participated in a previous blinded study of SPN-812 ER (812P202, 812P301, 812P302, 812P303, and 812P304). All pediatric subjects who complete a blinded study of SPN-812 ER will have the option to participate in this study in which all subjects will receive SPN-812 ER at an optimized dose. After an initial dose, subjects will enter an dose optimization phase of up to twelve weeks. Following optimization, subjects will return to the clinic every 3 months for up to 72 months or until the subject discontinues or the availability of SPN 812 on the market, whichever occurs first.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Treatment
Arm Type
Experimental
Arm Description
Subjects 6-11 yrs of age will be treated with 100 to 400 mg SPN-812 ER (100 mg capsule). Subjects 12-17 yrs of age will be treated with 100 to 600 mg SPN-812 ER (100, 200 mg capsule). Subjects are given a choice to extend their participation in the study every 6 months for up to 72 months.
Intervention Type
Drug
Intervention Name(s)
SPN-812
Other Intervention Name(s)
viloxazine extended-release
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Change from Baseline
Time Frame
72 months
Secondary Outcome Measure Information:
Title
Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or ADHD-RS-5) Score
Description
Change from Baseline in ADHD-RS Total score by visit
Time Frame
ADHD-RS will be administered at baseline and every 3 months for up to 72 months
Title
Trends in Clinical Global Impression-Improvement (CGI-I) scale score
Description
CGI-I score by visit
Time Frame
CGI-I will be assessed post-baseline every 3 months for up to 72 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completion of a previous double-blind study of SPN-812 for the treatment of ADHD. Continues to be medically healthy with clinically normal laboratory profiles, vital signs and electrocardiograms. Weight of at least 20 kg if 6-11 years old and at least 35 kg for subjects aged 12 years and up. Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); written Informed Assent/Consent obtained from the subject if appropriate. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose and throughout the study: simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration surgically sterile male partner simultaneous use of male condom and diaphragm with spermicide established hormonal contraceptive Exclusion Criteria: Current diagnosis of significant systemic disease and/or of a major psychiatric or neurological disorder, including history or family history of seizures or seizure-like disorders. History of Major Depressive Disorder is allowed if the patient is free of episodes currently and for the last six months. Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS). BMI greater than 95th percentile for the appropriate age and gender (according to the CDC BMI-for-Age Growth Charts for boys and girls). Pregnancy, breastfeeding or refusal to practice contraception during the study for FOCP. Current substance or alcohol use. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Rubin, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Alliance for Wellness dba Alliance for Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
MCB Clinical Research Centers, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Meridien Research at Florida Clinical Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Indago Research & Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Florida Clinical Research Center, LLC.
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Paradigm Research Professionals
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
CNS Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Bayou City Research Corporation
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Road Runner Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Ericksen Research & Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Northwest Clinical Trials
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 Extended Release (ER)

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