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

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ClinicalTrials.gov Identifier: NCT02736656
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

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
Attention Deficit Hyperactivity Disorder Drug: SPN-812 ER 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 studies 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 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 or until the subject discontinues or the study ends at 36 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
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 : February 2, 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open-Label Treatment
Subjects aged 6-12 years will be treated with SPN-812 ER followed by dose optimization. The subject will be given a choice to extend their participation in the study every 6-months for up to 36 months.
Drug: SPN-812 ER



Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 36 months ]
    Change from Baseline


Secondary Outcome Measures :
  1. Trends in Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or ADHD-RS-5) Score [ Time Frame: ADHD-RS will be administered at baseline and every 3 months for upto 36 months ]
    Change from Baseline in ADHD-RS Total score

  2. Trends in Clinical Global Impression-Improvement (CGI-I) score [ Time Frame: CGI-I will be assessed at baseline and every 3 months for up to 36 months ]
    Change from Baseline in CGI-I score



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Completion of a previous blinded study of SPN-812 ER for the treatment of ADHD.
  2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms.
  3. Weight of at least 20 kg.
  4. Written Informed Consent obtained from the subject's parent or legally authorized representative; written Informed Assent obtained from the subject if appropriate.

Exclusion Criteria:

  1. Diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
  2. Currently meeting Diagnostic and Statistical Manual of Mental Disorders-5 criteria for an anxiety disorder as primary diagnosis.
  3. Current evidence of suicidality (suicidal thoughts or behaviors).
  4. Body Mass Index greater than 95th percentile for the appropriate age and gender.
  5. Pregnancy, or refusal to practice contraception during the study (for female subjects of childbearing potential).
  6. Current substance or alcohol use.
  7. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736656


Contacts
Contact: Stefan Schwabe, MD, PhD 301-838-2527 sschwabe@supernus.com
Contact: Azmi Nasser, PhD 2404035303 anasser@supernus.com

Locations
United States, Arkansas
Woodland International Research Group Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Jim Aukstuolis, MD    501-221-8681    drjim@woodlandintlresearchgrp.com   
United States, California
Alliance for Wellness dba Alliance for Research Recruiting
Long Beach, California, United States, 90807
Contact: Elizabeth Zarate-Rowell, MD    562-548-8500    erowell@allianceforresearch.com   
United States, Colorado
MCB Clinical Research Centers, LLC Recruiting
Colorado Springs, Colorado, United States, 80910
Contact: Andrew Sedillo, MD    719-634-6576    asedillo@mcbcrc.com   
United States, Florida
Meridien Research at Florida Clinical Research Center Recruiting
Bradenton, Florida, United States, 34201
Contact: Jose Zaglul, MD    941-747-7900    jzaglul@flcrc.com   
Sarkis Clinical Trials Recruiting
Gainesville, Florida, United States, 32607
Contact: Elias Sarkis, MD    352-333-0094    ok@ehsfamily.com   
Indago Research & Health Center, Inc. Recruiting
Hialeah, Florida, United States, 33012
Contact: Miguel Perez, MD    305-825-6588    mperez@indagoresearch.org   
Florida Clinical Research Center, LLC. Recruiting
Maitland, Florida, United States, 32751
Contact: Andrea Marraffino, PhD    407-644-1165    amarraffino@flcrc.com   
Florida Clinical Research Center, LLC Recruiting
Maitland, Florida, United States, 32751
Contact: Andrea Marraffino, PhD         
United States, Oklahoma
IPS Research Recruiting
Oklahoma City, Oklahoma, United States, 73103
Principal Investigator: Louise Beckett-Thurman, MD         
Paradigm Research Professionals Recruiting
Oklahoma City, Oklahoma, United States, 73118
Contact: Courtney Nixon, MD    405-286-2104    cnixon@researchok.com   
United States, Tennessee
Clinical Neuroscience Solutions, Inc. Recruiting
Memphis, Tennessee, United States, 38119
Principal Investigator: Dolores DiGaetano, MD         
CNS Healthcare Recruiting
Memphis, Tennessee, United States, 38119
Contact: Valerie Arnold, MD    901-843-1045    varnold@cnshealthcare.com   
United States, Texas
Bayou City Research Corporation Recruiting
Houston, Texas, United States, 77006
Contact: Matthew Brams, MD    832-251-7000    drmattbrams@aol.com   
Road Runner Research Recruiting
San Antonio, Texas, United States, 78258
Contact: Jerry Tomasovic, MD    210-949-0505    jtomasovic@rrresearchsa.com   
United States, Utah
Ericksen Research & Development Recruiting
Clinton, Utah, United States, 84015
Contact: Samantha Bostrom, MD    801-614-5501    medicalway@aol.com   
United States, Washington
Northwest Clinical Trials Recruiting
Bellevue, Washington, United States, 98004
Principal Investigator: Arif Khan, MD         
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02736656     History of Changes
Other Study ID Numbers: 812P310
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms