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

• ClinicalTrials.gov Identifier: NCT03247556
• Recruitment Status: Completed
• First Posted: August 11, 2017
• Last Update Posted: August 19, 2020
• Sponsor: Supernus Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Supernus Pharmaceuticals, Inc.

Study Description

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: 400mg SPN-812 ER; Drug: 600mg 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 12-17 years old with ADHD.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 297 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 400 and 600 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
• Actual Study Start Date: November 20, 2017
• Actual Primary Completion Date: February 14, 2019
• Actual Study Completion Date: February 14, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo qd	Drug: Placebo; Placebo will be administered once daily; Other Name: PBO
Experimental: 400mg SPN-812 ER; 400mg SPN-812 ER qd	Drug: 400mg SPN-812 ER; SPN-812 ER high dose A will be administered once daily and compared to Placebo; Other Name: SPN-812 ER High Dose A
Experimental: 600mg SPN-812 ER; 600mg SPN-812 ER qd	Drug: 600mg SPN-812 ER; SPN-812 ER high dose B will be administered once daily and compared to Placebo; Other Name: SPN-812 ER High Dose B

Outcome Measures

Primary Outcome Measures :

1. Efficacy of SPN-812 ER assessed by ADHD-RS-5 Rating Sc [ Time Frame: 7 weeks ]
   Change from Baseline to End of Study in the ADHD-RS-5 tot

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 50% Responder Rate [ Time Frame: 7 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: 7 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: 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-I) Scale [ Time Frame: 7 weeks ]
   Change from Baseline to End of Study in CGI-I score

Eligibility Criteria

• 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 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)

Contacts and Locations

Locations

United States, California

Alliance for Wellness dba Alliance for Research

Long Beach, California, United States, 90807

United States, Colorado

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, United States, 80910

United States, Florida

Meridien Research at Florida Clinical Research Center

Bradenton, Florida, United States, 34201

Innovative Clinical Research, Inc

Lauderhill, Florida, United States, 33319

Miami Clinical Research

Miami, Florida, United States, 33155

APG Research, LLC

Orlando, Florida, United States, 32803

United States, Georgia

iResearch Atlanta

Decatur, Georgia, United States, 30030

United States, Oklahoma

IPS Research

Oklahoma City, Oklahoma, United States, 73103

Paradigm Research Professionals

Oklahoma City, Oklahoma, United States, 73118

United States, South Carolina

Carolina Clinical Trials, Inc.

Charleston, South Carolina, United States, 29407

United States, Texas

Gadolin Research, LLC

Beaumont, Texas, United States, 77702

Bayou City Research Corporation

Houston, Texas, United States, 77006

Dicovery MM Services Inc. Houston

Houston, Texas, United States, 77061

United States, Utah

Ericksen Research & Development

Clinton, Utah, United States, 84015

Sponsors and Collaborators

Supernus Pharmaceuticals, Inc.

Investigators

• Study Director: Stefan Schwabe, MD; Supernus Pharmaceuticals, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nasser A, Kosheleff AR, Hull JT, Liranso T, Qin P, Busse GD, O'Neal W, Fava M, Faraone SV, Rubin J. Translating Attention-Deficit/Hyperactivity Disorder Rating Scale-5 and Weiss Functional Impairment Rating Scale-Parent Effectiveness Scores into Clinical Global Impressions Clinical Significance Levels in Four Randomized Clinical Trials of SPN-812 (Viloxazine Extended-Release) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Feb 17. doi: 10.1089/cap.2020.0148. [Epub ahead of print]

• Responsible Party: Supernus Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03247556
• Other Study ID Numbers: 812P304
• First Posted: August 11, 2017
• Last Update Posted: August 19, 2020
• Last Verified: August 2020

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