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

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ClinicalTrials.gov Identifier: NCT03247556
Recruitment Status : Not yet recruiting
First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
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 adolescents (12-17 years old)

Condition or disease Intervention/treatment Phase
ADHD Drug: Placebo Drug: SPN-812 ER High Dose A Drug: SPN-812 ER High Dose B Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 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 High Dose in Adolescents With ADHD
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Arm Intervention/treatment
Experimental: Placebo Drug: Placebo
Placebo will be administered once daily

Active Comparator: SPN-812 ER High Dose A Drug: SPN-812 ER High Dose A
SPN-812 ER high dose A will be administered once daily and compared to Placebo

Active Comparator: SPN-812 ER High Dose B Drug: SPN-812 ER High Dose B
SPN-812 ER high dose B will be administered once daily and compared to Placebo




Primary Outcome Measures :
  1. Efficacy of SPN-812 ER assessed by ADHD-RS- V Rating Scale [ Time Frame: 7 weeks ]
    Change from Baseline to End of Study in ADHD-RS-V Rating Scale Score


Secondary Outcome Measures :
  1. Effect of SPN-812 ER assessed by Conners 3 Rating Scale [ Time Frame: 7 weeks ]
    Change from Baseline to End of Study in Conners 3 Rating Scale Score

  2. Effect of SPN-812 ER assessed by 30% Responder Rate [ Time Frame: 7 weeks ]
    Percentage of subjects with at least a 30% improvement in ADHD-RS-V Total Score from Baseline to End of study

  3. Effect of SPN-812 ER assessed by ADHD Subscores [ Time Frame: 7 weeks ]
    Change from Baseline to End of Study in hyperactivity/impulsivity and inattention subscales

  4. Effect of SPN-812 ER assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) [ Time Frame: 7 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: 7 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-S/I) Scale [ Time Frame: 7 weeks ]
    Change from Baseline to End of Study in CGI-S/I score



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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-V (DSM V), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
  3. Attention Deficit/Hyperactivity Disorder Rating Scale-V, Home Version: Adolescent, Investigator Administered and Scored (ADHD-RS-V) 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 psychological 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 ClinicalTrials.gov identifier (NCT number): NCT03247556


Contacts
Contact: Janet Johnson, PhD 301-502-7856 jjohnson@supernus.com

Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03247556     History of Changes
Other Study ID Numbers: 812P304
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
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