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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.

Tracking Information
First Submitted Date  ICMJE August 9, 2017
First Posted Date  ICMJE August 11, 2017
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE November 2, 2017
Actual Primary Completion Date October 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
Efficacy of SPN-812 ER assessed by ADHD-RS-V Rating Scale [ Time Frame: 6 weeks ]
Change from Baseline to End of Study in the ADHD-RS-V total score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
  • 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
  • Effect of SPN-812 ER assessed by 30% Responder rate [ Time Frame: 6 weeks ]
    Percentage of subjects with at least a 30% improvement in ADHD-RS-V total score from Baseline to End of Study
  • Effect of SPN-812 ER assessed by ADHD subscores [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in hyperactivity/impulsivity and inattention subscales of ADHD-RS-V
  • 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
  • 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
  • Effect of SPN-812 ER assessed by Clinical Global Impression - Severity of Illness and Improvement (CGI-S/I) Scale [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in CGI-S/I score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of SPN-812 ER Low Dose in Adolescents With ADHD
Official Title  ICMJE Evaluation of SPN 812 ER 200 and 400 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
Brief Summary This study will evaluate the efficacy and safety of low doses of SPN-812 ER in adolescents 12-17 years of age.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ADHD
Intervention  ICMJE
  • Drug: Placebo
    Placebo will be administered once daily
    Other Name: PBO
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo qd
    Intervention: Drug: Placebo
  • Experimental: 200mg SPN-812 ER
    200mg SPN-812 ER qd
    Intervention: Drug: 200mg SPN-812 ER
  • Experimental: 400mg SPN-812 ER
    400mg SPN-812 ER qd
    Intervention: Drug: 400mg SPN-812 ER
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2019)
310
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2017)
300
Actual Study Completion Date  ICMJE October 17, 2018
Actual Primary Completion Date October 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03247517
Other Study ID Numbers  ICMJE 812P302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Supernus Pharmaceuticals, Inc.
Study Sponsor  ICMJE Supernus Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stefan Schwabe Supernus Pharmaceuticals, Inc.
PRS Account Supernus Pharmaceuticals, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP