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

NCT ID: NCT03247530

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 477 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-20
• Study Completion Date: 2018-09-12

Brief Summary

This study will evaluate the efficacy and safety of low doses of SPN-812 in children 6-11 years of age diagnosed 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 monotherapy for the treatment of children 6-11 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

100mg SPN-812

100mg SPN-812, qd, oral capsule

Group Type: EXPERIMENTAL

100mg SPN-812

Intervention Type: DRUG

100mg SPN-812 was administered once daily and compared to placebo

200mg SPN-812

200mg SPN-812, qd, oral capsule

Group Type: EXPERIMENTAL

200mg SPN-812

Intervention Type: DRUG

200mg SPN-812 was administered once daily and compared to placebo

Interventions

Placebo

Placebo was administered once daily

Intervention Type: DRUG

100mg SPN-812

100mg SPN-812 was administered once daily and compared to placebo

Intervention Type: DRUG

200mg SPN-812

200mg 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, 6-11 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: Child, 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 20 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: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Schwabe, MD

Role: STUDY_DIRECTOR

Supernus Pharmaceuticals, Inc.

Locations

Harmonex Neuroscience Research

Dothan, Alabama, United States

Indago Research & Health Center, Inc.

Hialeah, Florida, United States

Advanced Clinical Research

Meridian, Idaho, United States

Finger Lakes Clinical Research

Rochester, New York, United States

Houston Clinical Trials

Houston, Texas, United States

Family Psychiatry of the Woodlands

The Woodlands, Texas, United States

Aspen Clinical Research

Orem, 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)

Nasser A, Liranso T, Adewole T, Fry N, Hull JT, Chowdhry F, Busse GD, Cutler AJ, Jones NJ, Findling RL, Schwabe S. A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit/Hyperactivity Disorder in School-age Children. Clin Ther. 2020 Aug;42(8):1452-1466. doi: 10.1016/j.clinthera.2020.05.021. Epub 2020 Jul 25.

Reference Type: DERIVED

PMID: 32723670 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

812P301

Identifier Type: -

Identifier Source: org_study_id