Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)

NCT ID: NCT02736656

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-02
• Study Completion Date: 2026-09-30

Brief Summary

Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients

Detailed Description

This is a multicenter open-label extension study assessing long term safety and efficacy of SPN-812 (viloxazine extended-release capsules) in pediatric subjects with ADHD (A) who completed a Phase 2 (812P202: children 6 to 12 years of age) or one of four Phase 3 trials (812P301/812P303: children 6 to 11 years of age; 812P302/812P304: adolescents 12 to 17 years of age) or (B) who completed a Phase 4 trial (812P401: preschool-age children, 4-5 years of age). The study is divided into two phases, Optimization and Maintenance phases. Subjects in Cohort 'A' who completed a Phase 2 or Phase 3 trial followed protocol Schedule 'A' (exposure up to 72 months). Subjects in Cohort 'B' who complete the Phase 4 trial will follow Schedule 'B' (exposure up to 6 months).

Conditions

Attention-Deficit/Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-Label Treatment

Cohort 'A': Pediatric subjects 6-17 years of age who completed a Phase 2 (Study 812P202) or one of four Phase 3 trials (Study 812P301-P304).

Cohort 'B': Pediatric subjects 4-5 years of age who completed a Phase 4 trial.

Group Type: EXPERIMENTAL

SPN-812

Intervention Type: DRUG

Cohort 'A': Children 6-11 yrs of age take 100-400mg SPN-812 once daily by mouth and adolescents 12-17 yrs of age take 100-600mg SPN-812 once daily by mouth. Pediatric subjects in Cohort 'A' are given a choice to extend their participation in the study every 6 months for up to 72 months.

Cohort 'B': Pre-school-age children 4-5 yrs of age take 100mg SPN-812 once daily by mouth. Pediatric subjects in Cohort 'B' will be treated with 100 mg SPN-812 (100 mg capsule) for up to 6 months.

Interventions

SPN-812

Cohort 'A': Children 6-11 yrs of age take 100-400mg SPN-812 once daily by mouth and adolescents 12-17 yrs of age take 100-600mg SPN-812 once daily by mouth. Pediatric subjects in Cohort 'A' are given a choice to extend their participation in the study every 6 months for up to 72 months.

Cohort 'B': Pre-school-age children 4-5 yrs of age take 100mg SPN-812 once daily by mouth. Pediatric subjects in Cohort 'B' will be treated with 100 mg SPN-812 (100 mg capsule) for up to 6 months.

Intervention Type: DRUG

Other Intervention Names

viloxazine extended-release capsules

Eligibility Criteria

Inclusion Criteria

1. Completion of a previous blinded study of SPN-812 for the treatment of ADHD.

2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).

3. Weight of at least 20 kg if 6-11 years old and at least 35 kg if 12 years or older.

4. Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); and written Informed Assent obtained from the subject if appropriate; written Informed Consent obtained from the subject if he/she is 18 years old.

5. 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

1. Has completed a previous Study 812P401 and is less than 6 years of age at Visit 1 in this study (812P310).

2. Continues to be medically healthy with clinically normal laboratory profiles, vital signs, and electrocardiograms.

3. Weighs at least ≥5th percentile for age and sex.

4. Parent or LAR is willing and able to provide Written Informed Consent.

Exclusion Criteria

1. Current diagnosis of significant systemic disease or of a major psychiatric or neurological disorder, including history or family history of seizures or seizure-like disorders. History of Major Depressive Disorder is allowed if the subject is free of episodes currently and for the last six months.

2. Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS).

3. Body Mass Index (BMI) greater than 95th percentile for the appropriate age and gender (according to the CDC BMI-for-Age Growth Charts for boys and girls).

4. Pregnancy, breastfeeding, or refusal to practice contraception during the study for female subjects of childbearing potential (FOCP).

5. Current substance or alcohol use.

6. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

1. Has a current diagnosis of significant systemic disease and/or of a major psychiatric or neurological disorder.

2. Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS), is at significant risk of suicide, either in the opinion of the Investigator or defined as a "yes" to suicidal ideation C-SSRS questions 4 or 5 or answering "yes" to suicidal behavior on the C-SSRS at Visit 1 or has attempted suicide from day of end of study in previous blinded study to day of Visit 1 in this study (812P310).

3. Has a BMI >95th percentile for the appropriate age and sex (according to the CDC BMI-for-Age Growth Charts for boys and girls).

4. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 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, MBA

Role: STUDY_DIRECTOR

Supernus Pharmaceuticals, Inc.

Locations

Woodland International Research Group

Little Rock, Arkansas, United States

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

Sarkis Clinical Trials

Gainesville, Florida, United States

Indago Research & Health Center, Inc.

Hialeah, Florida, United States

Florida Clinical Research Center, LLC.

Maitland, Florida, United States

Florida Clinical Research Center, LLC

Maitland, Florida, United States

IPS Research

Oklahoma City, Oklahoma, United States

Paradigm Research Professionals

Oklahoma City, Oklahoma, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

CNS Healthcare

Memphis, Tennessee, United States

Bayou City Research Corporation

Houston, Texas, United States

Road Runner Research

San Antonio, Texas, United States

Ericksen Research & Development

Clinton, Utah, United States

Northwest Clinical Trials

Bellevue, Washington, United States

Countries

United States

References

Findling RL, Katic A, Liebowitz M, Waxmonsky J, Fry N, Qin P, Yarullina I, Maldonado-Cruz Z, Lieberman VR, Rubin J. Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Results of a Long-Term, Phase 3, Open-Label Extension Trial. CNS Drugs. 2025 Nov;39(11):1157-1172. doi: 10.1007/s40263-025-01209-0. Epub 2025 Aug 13.

Reference Type: DERIVED

PMID: 40802027 (View on PubMed)

Other Identifiers

812P310

Identifier Type: -

Identifier Source: org_study_id