Evaluation of SPN-812 ER High Dose in Children With ADHD

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: NCT03247543
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : September 6, 2018
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

Brief Summary:
This study will evaluate the efficacy and safety of high doses of SPN 812 ER in children with ADHD

Condition or disease Intervention/treatment Phase
ADHD Drug: Placebo Drug: 200mg SPN-812 ER Drug: 400mg SPN-812 ER Phase 3

Detailed Description:
This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group study, to assess the efficacy and safety of SPN-812 ER as monotherapy for the treatment of children 6-11 years old with ADHD.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Evaluation of SPN 812 ER 200 and 400 mg Efficacy and Safety in Children With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo qd
Drug: Placebo
Placebo qd

Active Comparator: 200mg SPN-812 ER
200mg SPN-812 ER qd
Drug: 200mg SPN-812 ER
200mg SPN-812 ER qd

Active Comparator: 400mg SPN-812 ER
400mg SPN-812 ER qd
Drug: 400mg SPN-812 ER
400mg SPN-812 ER qd

Primary Outcome Measures :
  1. Efficacy of SPN-812 ER assessed by ADHD-RS-5 Rating Scale [ Time Frame: 8 weeks ]
    Change from Baseline to End of Study in the ADHD-RS-5 total score

Secondary Outcome Measures :
  1. Effect of SPN-812 ER assessed by Conners 3 Rating Scale [ Time Frame: 8 weeks ]
    Change from Baseline to End of Study in Conners 3 score

  2. Effect of SPN-812 ER assessed by 50% Responder Rate [ Time Frame: 8 weeks ]
    Percentage of subjects with at least a 50% improvement in ADHD-RS-V Total score from Baseline to End of Study

  3. Effect of SPN-812 ER assessed by ADHD-RS-5 Subscores [ Time Frame: 8 weeks ]
    Change from Baseline to End of Study in hyperactivity/impulsivity and inattention subscales of ADHD-RS-5

  4. Effect of SPN-812 ER assessed by Weiss Functional Impairment Rating Scale- Parent report (WFIRS-P) [ Time Frame: 8 weeks ]
    Change from Baseline to End-of Study in WFIRS-P Score

  5. Effect of SPN-812 ER assessed by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF) [ Time Frame: 8 weeks ]
    Change from Baseline to End-of Study in PSI-4-SF Score

  6. Effect of SPN-812 ER assessed by Clinical Global Impression-Severity of Illness and Improvement (CGI-I) Scale [ Time Frame: 8 weeks ]
    Change from Baseline to End of Study in CGI-I score

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Healthy male or female subjects, 6-11 years of age, inclusive.
  2. Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
  3. Attention Deficit/Hyperactivity Disorder Rating Scale-5, Home Version: Child, Investigator Administered and Scored (ADHD-RS-5) score of at least 28.
  4. CGI-S score of at least 4 at screening.
  5. Weight of at least 20 kg.
  6. Free of medication for the treatment of ADHD for at least one week prior to randomization and agreement to remain so throughout the study.
  7. Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram.
  8. Written informed consent obtained from the subject's parent or legal representative and informed assent from the subject, if applicable.
  9. 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, 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 major psychiatric disorders. Subjects with Major Depressive Disorder are allowed in the study if the subject is free of episodes both currently and for the last six months.
  2. Current diagnosis of major neurological disorders. Subjects with seizures or a history of seizure disorder within the immediate family (siblings, parents), or a history of seizure-like events are excluded from the study.
  3. Current diagnosis of significant systemic disease.
  4. Evidence of suicidality (defined as either active suicidal plan/intent or active suicidal thoughts, or more than one lifetime suicide attempt) within the six months before Screening or at Screening.
  5. BMI greater than 95th percentile for the appropriate age and gender.
  6. History of an allergic reaction to viloxazine or related drugs.
  7. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study.
  8. Subjects who received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 1 dosing of SM.
  9. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
  10. Positive drug screen at the Screening Visit. A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening; the subject will be required to discontinue the stimulant for the study, beginning at least one week prior to the Baseline Visit.
  11. Pregnancy or refusal to practice abstinence or acceptable birth control during the study (for female subjects of childbearing potential)

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): NCT03247543

Contact: Fatima Chowdhry, MD 240-403-5375
Contact: Azmi Nasser, Phd 2404035303

United States, California
Alliance for Wellness Recruiting
Long Beach, California, United States, 90807
United States, Florida
Innovative Clinical Research, Inc Recruiting
Lauderhill, Florida, United States, 33319
Contact: Rishi Kakar, MD    954-990-6326   
APG Research, LLC Recruiting
Orlando, Florida, United States, 32803
Contact: Nadjafi Morteza, MD    407-423-7149 ext 165   
University of South Florida- Dept. of Psychiatry and Neurosciences Recruiting
Tampa, Florida, United States, 33613
Contact: Daniel Fallon, MD    813-974-2832   
United States, Kansas
Psychiatric Associates Recruiting
Overland Park, Kansas, United States, 66211
Contact: William Muphy, MD    913-438-8221   
United States, Oklahoma
Paradigm Research Professionals Recruiting
Oklahoma City, Oklahoma, United States, 73118
Contact: Courtney Nixon, MD    405-286-2104   
United States, South Carolina
Carolina Clinical Trials, Inc. Recruiting
Charleston, South Carolina, United States, 29407
Contact: Steven Lopez, MD    843-576-6750   
United States, Texas
BioBehavioral Research of Austin P.C. Active, not recruiting
Austin, Texas, United States, 78759
Bayou City Research Corporation Recruiting
Houston, Texas, United States, 77006
Contact: Matthew Brams, MD    832-251-7000   
United States, Utah
Ericksen Research & Development Recruiting
Clinton, Utah, United States, 84015
Contact: Samantha Bostrom, MD    801-614-5501   
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
Study Director: Stefan Schwabe, MD Supernus Pharmaceuticals, Inc.

Responsible Party: Supernus Pharmaceuticals, Inc. Identifier: NCT03247543     History of Changes
Other Study ID Numbers: 812P303
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No