Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-06 @ 8:02 AM
Study NCT ID:
NCT04016792
Status:
WITHDRAWN
Last Update Posted:
2019-09-18
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Classroom Study of SPN-812 in Children With ADHD
Sponsor:
Supernus Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
An Analog Classroom Study: Efficacy and Safety of SPN-812 in Children With Attention-Deficit/Hyperactivity Disorder
Status:
WITHDRAWN
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped before enrollment due to non-safety related corporate decision.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the efficacy and safety of SPN-812, an extended-release formulation of viloxazine, compared to placebo in children in an analog classroom setting.
Detailed Description:
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 2-arm, analog classroom study to evaluate the efficacy and safety of 200 mg/day SPN-812 compared to placebo in the treatment of children aged 6 through 11 years with ADHD.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: