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

Phase 3

Active, not recruiting

• Conditions: Attention-Deficit/Hyperactivity Disorder
• Interventions: Drug: SPN-812

• Registration Number: NCT02736656
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

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).

Study Timeline

• Study Start: 2016-02-02
• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

Not provided

Exclusion Criteria

Inclusion Criteria 'A':

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

Exclusion Criteria 'A':

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.

Cohort 'B' Inclusion/Exclusion Criteria:

Inclusion Criteria 'B':

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 'B':

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-Label Treatment	SPN-812	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.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	up to 72 months	The incidence (percentage of subjects dosed) of adverse events by System Organ Class and Preferred term by cohort

Secondary Outcome Measures

Name	Time	Method
Trends in Clinical Global Impression-Improvement (CGI-I) scale score	up to 72 months	CGI-I score by visit by cohort
Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV-Preschool, ADHD-RS-IV or ADHD-RS-5) Score	up to 72 months	Change from Baseline in ADHD-RS Total score by visit by cohort

Trial Locations

Locations (16)

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

Scroll for more (6 remaining)