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Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Adolescents With ADHD

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ClinicalTrials.gov Identifier: NCT03247517
Recruitment Status : Completed
First Posted : August 11, 2017
Results First Posted : June 18, 2021
Last Update Posted : June 18, 2021
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 in adolescents 12-17 years of age.

Condition or disease Intervention/treatment Phase
ADHD Drug: Placebo Drug: 200mg SPN-812 Drug: 400mg SPN-812 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 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 (Viloxazine Extended-release Capsule) 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, oral capsule
Drug: Placebo
Placebo was administered once daily
Other Name: PBO

Experimental: 200mg SPN-812
200mg SPN-812, qd, oral capsule
Drug: 200mg SPN-812
200mg SPN-812 was administered once daily and compared to placebo
Other Name: SPN-812

Experimental: 400mg SPN-812
400mg SPN-812, qd, oral capsule
Drug: 400mg SPN-812
400mg SPN-812 was administered once daily and compared to placebo
Other Name: SPN-812




Primary Outcome Measures :
  1. Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) [ Time Frame: Baseline and Week 6 (End of Study) ]
    The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 6 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (<0) represent a better outcome.


Secondary Outcome Measures :
  1. Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Week 6 (End of Study) ]
    The first Key Secondary Endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 6 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = "very much improved" and 7 = "very much worse." Successful therapy is indicated by a lower overall score in subsequent testing.

  2. Effect of SPN-812 Assessed by Conners 3rd Edition - Parent Short Form (C3-PS) [ Time Frame: Baseline and Week 6 (End of Study) ]
    The second Key Secondary Endpoint was the change from baseline in the Conners 3rd Edition - Parent Short Form (C3PS) Composite T-score at Week 6 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS is completed by a child's parent/guardian and is comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rates his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently]) based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (<0) represent a better outcome.

  3. Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) [ Time Frame: Baseline and Week 6 (End of Study) ]
    The third Key Secondary Endpoint was the change from baseline in the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) Total Average score at Week 6 (End of Study). The WFIRS instrument evaluates ADHD-related functional impairment. The WFIRS-P is completed by the child's parent/guardian and is comprised of 50 items grouped into six domains: Family (10 items), School (10 items, includes learning [4 items] and behavior [6 items]), Life Skills (10 items), Child's Self-Concept (3 items), Social Activities (7 items), and Risky Activities (10 items). The parent/guardian rates each item on a 4-point Likert scale (0-3; where 0=never or not at all to 3= very often or very much) based on their child's behavior past month. A Total Average score was computed by calculating mean rating of all 50 items (ranging from 0 to 3, where a higher value represents more severe functional impairment). Lower change from baseline Total Average scores (<0) represent a better outcome.

  4. Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) [ Time Frame: Week 6 (End of Study) ]
    An additional secondary endpoint was the percentage of responders at Week 6 (End of Study). A responder was defined as a subject who had a 50% or greater reduction (improvement) in their change from baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 6 (End of Study). Values range from 0 to 100%. A higher percentage represents a greater number of responders.

  5. Effect of SPN-812 Assessed by Stress Index for Parents of Adolescents (SIPA) [ Time Frame: Baseline and Week 6 (End of Study) ]
    Another secondary endpoint was the change from baseline in the Stress Index for Parents of Adolescents (SIPA) Total score to Week 6 (End of Study). The SIPA is a 112-item screening/diagnostic instrument for parents of adolescents 11-19 years of age that identifies areas of stress in parent-adolescent interactions. Items 1-90 are rated on a 5-point Likert scale (where SD=Strongly Disagree, D=Disagree, NS=Not Sure, A=Agree, and SA=Strongly Agree) and yields a raw score for 3 Domains (Adolescent Domain, Parent Domain, and Adolescent-Parent Domain) that focus on a parent's perception of their child's personality and on the parent's characteristics and behaviors. The sum of the 3 Domain scores yields the Total (Parent Stress) score (range: 90-450; higher total scores indicate higher levels of stress). Lower change from baseline scores (<0) represent a better outcome.

  6. Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) [ Time Frame: Baseline and Week 6 (End of Study) ]
    An additional secondary endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Hyperactivity/Impulsivity subscale score and Inattention subscale score at Week 6 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 DSM-5 symptoms of ADHD, including 9 items for the Hyperactivity/Impulsivity subscale and 9 items for the Inattention subscale. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). Each subscale score is calculated by adding the responses of all respective 9 items (range: 0-27; the higher the subscale score, the more severe the Hyperactivity/Impulsivity or Inattention symptoms). Lower change from baseline subscale scores (<0) represent a better outcome.

  7. Effect of SPN-812 Assessed by Conners 3rd Edition - Self Report Short Form (C3-SRS) [ Time Frame: Baseline and Week 6 (End of Study) ]
    An additional secondary endpoint was the change from baseline in the Conners 3rd Edition - Self Report Short Form (C3-SRS) Composite T score at Week 6 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3-SRS, which is only validated in children/adolescents 8-18 years of age, is comprised of 41 items with subsets of items related to five content scales: inattention, hyperactivity/impulsivity, learning problems, aggression and family relations. The subject rates himself/herself on the first 39 items of C3-SRS using a 4-point Likert scale (0-3; where 0=not at all true [never, seldom] and 3=very much true [very often, very frequently] based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (<0) represent a better outcome.

  8. Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"] [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]
    An additional secondary endpoint was the percentage of subjects who were "improved" by visit; "improved" was defined as a subject who had a Clinical Global Impression - Improvement (CGI-I) score of 1 = "Very Much Improved" or 2 = "Much Improved". Values range from 0 to 100%. A higher percentage represents a greater number of subjects who were "improved".



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.
  Study Documents (Full-Text)

Documents provided by Supernus Pharmaceuticals, Inc.:
Study Protocol  [PDF] September 18, 2018
Statistical Analysis Plan  [PDF] October 18, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Results First Posted: June 18, 2021
Last Update Posted: June 18, 2021
Last Verified: August 2020
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