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

NCT03247530 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 812P301
• Study Type: interventional
• Target: 477
• Locations: 1 country
• Sites: 7

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale, 5th Edition (ADHD-RS-5)

  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.

  Baseline and Week 6 (End of Study)

Secondary Outcomes (8)

• Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale

  Week 6 (End of Study)

• Effect of SPN-812 Assessed by Conners 3 - Parent Short Form (C3PS)

  Baseline and Week 6 (End of Study)

• Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)

  Baseline and Week 6 (End of Study)

• Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)

  Week 6 (End of Study)

• Effect of SPN-812 Assessed by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF)

  Baseline and Week 6 (End of Study)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo, qd, oral capsule

Drug: Placebo

100mg SPN-812

EXPERIMENTAL

100mg SPN-812, qd, oral capsule

Drug: 100mg SPN-812

200mg SPN-812

EXPERIMENTAL

200mg SPN-812, qd, oral capsule

Drug: 200mg SPN-812

Interventions

Placebo DRUG

Placebo was administered once daily

Also known as: PBO

Placebo

100mg SPN-812 DRUG

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

Also known as: SPN-812

100mg SPN-812

200mg SPN-812 DRUG

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

Also known as: SPN-812

200mg SPN-812

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male or female subjects, 6-11 years of age, inclusive.
• 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).
• Attention Deficit/Hyperactivity Disorder Rating Scale-5, Home Version: Child, Investigator Administered and Scored (ADHD-RS-5) score of at least 28.
• CGI-S score of at least 4 at screening.
• Weight of at least 20 kg.
• Free of medication for the treatment of ADHD for at least one week prior to randomization and agreement to remain so throughout the study.
• Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram.
• Written informed consent obtained from the subject's parent or legal representative and informed assent from the subject, if applicable.
• 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:
• simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration
• surgically sterile male partner
• simultaneous use of male condom and diaphragm with spermicide
• established hormonal contraceptive

You may not qualify if:

• 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.
• 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.
• Current diagnosis of significant systemic disease.
• 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.
• BMI greater than 95th percentile for the appropriate age and gender.
• History of an allergic reaction to viloxazine or related drugs.
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study.
• Subjects who received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 1 dosing of SM.
• Any reason, which, in the opinion of the Investigator, would prevent the subject from participating in the study.
• 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.
• Pregnancy or refusal to practice abstinence or acceptable birth control during the study (for female subjects of childbearing potential).

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (7)

Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

Location

Indago Research & Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Houston Clinical Trials

Houston, Texas, 77098, United States

Location

Family Psychiatry of the Woodlands

The Woodlands, Texas, 77381, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

Related Publications (5)

• 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.

  PMID: 36847750 DERIVED

• 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.

  PMID: 34523063 DERIVED

• 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.

  PMID: 33971070 DERIVED

• 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.

  PMID: 33600233 DERIVED

• 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.

  PMID: 32723670 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Joseph Hull, PhD, Associate Director Clinical Research
• Organization: Supernus

jhull@supernus.com

240-403-5324

Study Officials

• Stefan Schwabe, MD

  Supernus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 11, 2017
• Study Start: October 20, 2017
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: July 2, 2021
• Results First Posted: June 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)