Clinical trial NCT02736656: Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)
Official title: Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 for the Treatment of Pediatric Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Attention-Deficit/Hyperactivity Disorder
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-13
Enrollment: 1400
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 ≥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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 72 months
Secondary outcomes:
measure: Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or ADHD-RS-5) Score
timeFrame: ADHD-RS will be administered at baseline and every 3 months for up to 72 months
measure: Trends in Clinical Global Impression-Improvement (CGI-I) scale score
timeFrame: CGI-I will be assessed post-baseline every 3 months for up to 72 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Long Beach
country: United States
facility: Alliance for Wellness dba Alliance for Research
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
city: Bradenton
country: United States
facility: Meridien Research at Florida Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC.
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals
state: Oklahoma
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Houston
country: United States
facility: Bayou City Research Corporation
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research
state: Texas
city: Clinton
country: United States
facility: Ericksen Research & Development
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Trials
state: Washington
Study officials:
affiliation: Supernus Pharmaceuticals, Inc.
name: Jonathan Rubin, MD, MBA
role: STUDY_DIRECTOR
References: