Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 Extended Release (ER)

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title: Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 ER for the Treatment of Pediatric Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial Description

This is a multicenter, open-label extension study aimed to assess long-term safety and efficacy of SPN-812 ER when administered alone or in conjunction with an Food and Drug Administration-approved Attention Deficit Hyperactivity Disorder (ADHD) medication in the treatment of ADHD in pediatric subjects who have participated in a previous blinded study of SPN-812 ER (812P202, 812P301, 812P302, 812P303, and 812P304). All pediatric subjects who complete a blinded study of SPN-812 ER will have the option to participate in this study in which all subjects will receive SPN-812 ER at an optimized dose. After an initial dose, subjects will enter an dose optimization phase of up to twelve weeks. Following optimization, subjects will return to the clinic every 3 months for up to 72 months or until the subject discontinues or the availability of SPN 812 on the market, whichever occurs first. ;

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

• NCT number: NCT02736656
• Study type: Interventional
• Source: Supernus Pharmaceuticals, Inc.
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 2, 2016
• Completion date: June 2025