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 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 complete a Phase 4 trial (812P401). 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 24 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: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

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

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 ≥5th percentile for age and sex if 4 to 5 years old, 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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-Label Treatment	SPN-812	Cohort 'A' Subjects 6-11 yrs of age will be treated with 100 to 400 mg SPN-812 (100 mg capsule). Subjects 12-17 yrs of age will be treated with 100 to 600 mg SPN-812 (100, 200 mg capsule). Subjects are given a choice to extend their participation in the study every 6 months for up to 72 months. Cohort 'B' Subjects 4-5 yrs of age will be treated with 100 mg SPN-812 (100 mg capsule). Subjects may participate for up to 24 months.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	72 months	Change from Baseline

Secondary Outcome Measures

Name	Time	Method
Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or ADHD-RS-5) Score	ADHD-RS will be administered at baseline and every 3 months for up to 72 months	Change from Baseline in ADHD-RS Total score by visit
Trends in Clinical Global Impression-Improvement (CGI-I) scale score	CGI-I will be assessed post-baseline every 3 months for up to 72 months	CGI-I score by visit

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

Florida Clinical Research Center, LLC.; 🇺🇸 Maitland, Florida, United States

Florida Clinical Research Center, LLC; 🇺🇸 Maitland, Florida, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Memphis, Tennessee, United States

CNS Healthcare; 🇺🇸 Memphis, Tennessee, United States

Ericksen Research & Development; 🇺🇸 Clinton, Utah, United States

Northwest Clinical Trials; 🇺🇸 Bellevue, Washington, United States

MCB Clinical Research Centers, LLC; 🇺🇸 Colorado Springs, Colorado, United States

Meridien Research at Florida Clinical Research Center; 🇺🇸 Bradenton, Florida, United States

Indago Research & Health Center, Inc.; 🇺🇸 Hialeah, Florida, United States

Bayou City Research Corporation; 🇺🇸 Houston, Texas, United States

IPS Research; 🇺🇸 Oklahoma City, Oklahoma, United States

Paradigm Research Professionals; 🇺🇸 Oklahoma City, Oklahoma, United States

Road Runner Research; 🇺🇸 San Antonio, Texas, United States

Sarkis Clinical Trials; 🇺🇸 Gainesville, Florida, United States