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Evaluation of SPN-812 ER Low Dose in Adolescents 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03247517
Recruitment Status : Completed
First Posted : August 11, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

Brief Summary:
This study will evaluate the efficacy and safety of low doses of SPN-812 ER in adolescents 12-17 years of age.

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 adolescents 12-17 years old with ADHD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of SPN 812 ER 200 and 400 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
Actual Study Start Date : November 2, 2017
Actual Primary Completion Date : October 17, 2018
Actual Study Completion Date : October 17, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo qd
Drug: Placebo
Placebo will be administered once daily
Other Name: PBO

Experimental: 200mg SPN-812 ER
200mg SPN-812 ER qd
Drug: 200mg SPN-812 ER
SPN-812 low dose A will be administered once daily and compared to placebo
Other Name: SPN-812 ER Low Dose A

Experimental: 400mg SPN-812 ER
400mg SPN-812 ER qd
Drug: 400mg SPN-812 ER
SPN-812 Low Dose B will be administered once daily and compared to placebo
Other Name: SPN-812 ER Low Dose B




Primary Outcome Measures :
  1. Efficacy of SPN-812 ER assessed by ADHD-RS-5 Rating Scale [ Time Frame: 6 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: 6 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: 6 weeks ]
    Percentage of subjects with at least a 50% improvement in ADHD-RS-5 total score from Baseline to End of Study

  3. Effect of SPN-812 ER assessed by ADHD-RS-5 subscores [ Time Frame: 6 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: 6 weeks ]
    Change from Baseline to End of Study in WFIRS-P score

  5. Effect of SPN-812 ER assessed by Stress Index for Parents of Adolescents (SIPA) [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in SIPA score

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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Healthy male or female subjects, 12-17 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: Adolescent, 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 35 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 screen for drugs of abuse at the Screening Visit. A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening as long as the subject agrees to discontinue the stimulant for the duration of 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 ClinicalTrials.gov identifier (NCT number): NCT03247517


Locations
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United States, Alabama
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
United States, California
Neuropsychiatric Research Center of Orange County
Orange, California, United States, 92868
United States, Florida
Indago Research & Health Center, Inc.
Hialeah, Florida, United States, 33012
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States, 32217
Miami Clinical Research
Miami, Florida, United States, 33155
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
Texas Physicians Medical Research Group
Arlington, Texas, United States, 76014
Houston Clinical Trials
Houston, Texas, United States, 77098
Family Psychiatry of the Woodlands
The Woodlands, Texas, United States, 77381
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
Investigators
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Study Director: Stefan Schwabe Supernus Pharmaceuticals, Inc.

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Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03247517    
Other Study ID Numbers: 812P302
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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