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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02736656
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : April 14, 2016
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

Brief Summary:
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. 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. After an initial dose, subjects will enter an dose optimization phase for three to nine weeks. Following optimization, subjects will return to the clinic every 3 months or until the subject discontinues or the study ends at 36 months.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: SPN-812 ER Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

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 ]

Secondary Outcome Measures :
  1. Trends in Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score [ Time Frame: ADHD-RS-IV will be administered at baseline and every 3 months for upto 36 months ]
  2. Trends in Clinical Global Impression-Improvement (CGI-I) and Clinical Global Impression-Severity (CGI-S) score [ Time Frame: CGI-S will be assessed at baseline and every 3 months for up to 36 months and CGI-I will be assessed every 3 months for up to 36 months. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
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-V 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

Contact: Stefan Schwabe, MD, PhD 301-838-2527

United States, Florida
Florida Clinical Research Center, LLC Recruiting
Maitland, Florida, United States, 32751
Contact: Andrea Marraffino, PhD         
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.

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: April 14, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders