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Clinical Trials in the USA / NCT02736656
Active, not recruiting Phase 3

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

NCT02736656 · tracked via the Priya Life Science USA tracker
Sponsor
Supernus Pharmaceuticals, Inc.
Phase
Phase 3
Started
2016-02-02
Last updated
2026-07-15

Condition(s) studied

Attention-Deficit/Hyperactivity Disorder

Investigational drug(s) / intervention(s)

SPN-812

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.

Study summary

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

Eligibility

Sex
ALL
Min age
4 Years
Max age
18 Years
Healthy volunteers
No
Cohort 'A' Inclusion/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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Woodland International Research Group Little Rock Arkansas
Alliance for Wellness dba Alliance for Research Long Beach California
MCB Clinical Research Centers, LLC Colorado Springs Colorado
Meridien Research at Florida Clinical Research Center Bradenton Florida
Sarkis Clinical Trials Gainesville Florida
Indago Research & Health Center, Inc. Hialeah Florida
Florida Clinical Research Center, LLC. Maitland Florida
Florida Clinical Research Center, LLC Maitland Florida
IPS Research Oklahoma City Oklahoma
Paradigm Research Professionals Oklahoma City Oklahoma
Clinical Neuroscience Solutions, Inc. Memphis Tennessee
CNS Healthcare Memphis Tennessee
Bayou City Research Corporation Houston Texas
Road Runner Research San Antonio Texas
Ericksen Research & Development Clinton Utah
Northwest Clinical Trials Bellevue Washington

More Supernus Pharmaceuticals, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02736656 on ClinicalTrials.gov ↗ ← All trials in the USA