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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02736656
Recruitment Status : Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : October 14, 2019
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.

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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 up to 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT02736656

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United States, Arkansas
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
United States, California
Alliance for Wellness dba Alliance for Research
Long Beach, California, United States, 90807
United States, Colorado
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States, 80910
United States, Florida
Meridien Research at Florida Clinical Research Center
Bradenton, Florida, United States, 34201
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Indago Research & Health Center, Inc.
Hialeah, Florida, United States, 33012
Florida Clinical Research Center, LLC.
Maitland, Florida, United States, 32751
Florida Clinical Research Center, LLC
Maitland, Florida, United States, 32751
United States, Oklahoma
IPS Research
Oklahoma City, Oklahoma, United States, 73103
Paradigm Research Professionals
Oklahoma City, Oklahoma, United States, 73118
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
CNS Healthcare
Memphis, Tennessee, United States, 38119
United States, Texas
Bayou City Research Corporation
Houston, Texas, United States, 77006
Road Runner Research
San Antonio, Texas, United States, 78258
United States, Utah
Ericksen Research & Development
Clinton, Utah, United States, 84015
United States, Washington
Northwest Clinical Trials
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.

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Responsible Party: Supernus Pharmaceuticals, Inc. Identifier: NCT02736656     History of Changes
Other Study ID Numbers: 812P310
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms