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

NCT ID: NCT03247556

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-20
• Study Completion Date: 2019-02-14

Brief Summary

This study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents (12-17 years old) with ADHD

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 a monotherapy for the treatment of adolescents 12-17 years old with ADHD.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo, qd, oral capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo was administered once daily

400mg SPN-812

400mg SPN-812, qd, oral capsule

Group Type: EXPERIMENTAL

400mg SPN-812

Intervention Type: DRUG

400mg SPN-812 was administered once daily and compared to Placebo

600mg SPN-812

600mg SPN-812, qd, oral capsule

Group Type: EXPERIMENTAL

600mg SPN-812

Intervention Type: DRUG

600mg SPN-812 was administered once daily and compared to Placebo

Interventions

Placebo

Placebo was administered once daily

Intervention Type: DRUG

400mg SPN-812

400mg SPN-812 was administered once daily and compared to Placebo

Intervention Type: DRUG

600mg SPN-812

600mg SPN-812 was administered once daily and compared to Placebo

Intervention Type: DRUG

Other Intervention Names

PBO; SPN-812; SPN-812

Eligibility 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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Rubin, MD

Role: STUDY_DIRECTOR

Supernus Pharmaceuticals, Inc.

Locations

Alliance for Wellness dba Alliance for Research

Long Beach, California, United States

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, United States

Meridien Research at Florida Clinical Research Center

Bradenton, Florida, United States

Innovative Clinical Research, Inc

Lauderhill, Florida, United States

Miami Clinical Research

Miami, Florida, United States

APG Research, LLC

Orlando, Florida, United States

iResearch Atlanta

Decatur, Georgia, United States

IPS Research

Oklahoma City, Oklahoma, United States

Paradigm Research Professionals

Oklahoma City, Oklahoma, United States

Carolina Clinical Trials, Inc.

Charleston, South Carolina, United States

Gadolin Research, LLC

Beaumont, Texas, United States

Bayou City Research Corporation

Houston, Texas, United States

Discovery MM Services Inc. Houston

Houston, Texas, United States

Ericksen Research & Development

Clinton, Utah, United States

Countries

United States

References

Faraone SV, Gomeni R, Hull JT, Busse GD, Lujan B, Rubin J, Nasser A. Response of peer relations and social activities to treatment with viloxazine extended-release capsules (Qelbree(R) ): A post hoc analysis of four randomized clinical trials of children and adolescents with attention-deficit/hyperactivity disorder. Brain Behav. 2023 Apr;13(4):e2910. doi: 10.1002/brb3.2910. Epub 2023 Feb 27.

Reference Type: DERIVED

PMID: 36847750 (View on PubMed)

Faraone SV, Gomeni R, Hull JT, Busse GD, Melyan Z, Rubin J, Nasser A. Executive Function Outcome of Treatment with Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Post-Hoc Analysis of Four Randomized Clinical Trials. Paediatr Drugs. 2021 Nov;23(6):583-589. doi: 10.1007/s40272-021-00470-2. Epub 2021 Sep 15.

Reference Type: DERIVED

PMID: 34523063 (View on PubMed)

Nasser A, Kosheleff AR, Hull JT, Liranso T, Qin P, Busse GD, Fava M, Maletic V, Rubin J, Lopez F. Evaluating the likelihood to be helped or harmed after treatment with viloxazine extended-release in children and adolescents with attention-deficit/hyperactivity disorder. Int J Clin Pract. 2021 Aug;75(8):e14330. doi: 10.1111/ijcp.14330. Epub 2021 May 26.

Reference Type: DERIVED

PMID: 33971070 (View on PubMed)

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 Apr;31(3):214-226. doi: 10.1089/cap.2020.0148. Epub 2021 Feb 17.

Reference Type: DERIVED

PMID: 33600233 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

812P304

Identifier Type: -

Identifier Source: org_study_id