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

Sponsor
Supernus Pharmaceuticals, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02736656
Collaborator
(none)
1,200
Enrollment
16
Locations
1
Arm
99.9
Anticipated Duration (Months)
75
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Open label, flexible dose, long-term multicenter study of safety and efficacy of SPN-812 ER in pediatric ADHD patients

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Feb 2, 2016
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open-Label Treatment

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.

Drug: SPN-812
Other Names:
  • viloxazine extended-release

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events [72 months]

      Change from Baseline

    Secondary Outcome Measures

    1. Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or ADHD-RS-5) Score [ADHD-RS will be administered at baseline and every 3 months for up to 72 months]

      Change from Baseline in ADHD-RS Total score by visit

    2. Trends in Clinical Global Impression-Improvement (CGI-I) scale score [CGI-I will be assessed post-baseline every 3 months for up to 72 months]

      CGI-I score by visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    6. simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration

    7. surgically sterile male partner

    8. simultaneous use of male condom and diaphragm with spermicide

    9. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Woodland International Research Group Little Rock Arkansas United States 72211
    2 Alliance for Wellness dba Alliance for Research Long Beach California United States 90807
    3 MCB Clinical Research Centers, LLC Colorado Springs Colorado United States 80910
    4 Meridien Research at Florida Clinical Research Center Bradenton Florida United States 34201
    5 Sarkis Clinical Trials Gainesville Florida United States 32607
    6 Indago Research & Health Center, Inc. Hialeah Florida United States 33012
    7 Florida Clinical Research Center, LLC. Maitland Florida United States 32751
    8 Florida Clinical Research Center, LLC Maitland Florida United States 32751
    9 IPS Research Oklahoma City Oklahoma United States 73103
    10 Paradigm Research Professionals Oklahoma City Oklahoma United States 73118
    11 Clinical Neuroscience Solutions, Inc. Memphis Tennessee United States 38119
    12 CNS Healthcare Memphis Tennessee United States 38119
    13 Bayou City Research Corporation Houston Texas United States 77006
    14 Road Runner Research San Antonio Texas United States 78258
    15 Ericksen Research & Development Clinton Utah United States 84015
    16 Northwest Clinical Trials Bellevue Washington United States 98004

    Sponsors and Collaborators

    • Supernus Pharmaceuticals, Inc.

    Investigators

    • Study Director: Jonathan Rubin, MD, Chief Medical Officer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Supernus Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02736656
    Other Study ID Numbers:
    • 812P310
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Additional relevant MeSH terms:
    Hyperkinesis
    Attention Deficit Disorder with Hyperactivity
    Viloxazine

    Study Results

    No Results Posted as of Mar 21, 2022