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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,400

Participants

Timeline

Start Date

February 2, 2016

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Attention-Deficit/Hyperactivity Disorder
Interventions
DRUG

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."

Trial Locations (16)

32607

Sarkis Clinical Trials, Gainesville

32751

Florida Clinical Research Center, LLC., Maitland

Florida Clinical Research Center, LLC, Maitland

33012

Indago Research & Health Center, Inc., Hialeah

34201

Meridien Research at Florida Clinical Research Center, Bradenton

38119

Clinical Neuroscience Solutions, Inc., Memphis

CNS Healthcare, Memphis

72211

Woodland International Research Group, Little Rock

73103

IPS Research, Oklahoma City

73118

Paradigm Research Professionals, Oklahoma City

77006

Bayou City Research Corporation, Houston

78258

Road Runner Research, San Antonio

80910

MCB Clinical Research Centers, LLC, Colorado Springs

84015

Ericksen Research & Development, Clinton

90807

Alliance for Wellness dba Alliance for Research, Long Beach

98004

Northwest Clinical Trials, Bellevue

All Listed Sponsors
lead

Supernus Pharmaceuticals, Inc.

INDUSTRY