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)
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
Trial sites (16)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.