Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 4:41 AM
Study NCT ID:
NCT03247556
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD
Sponsor:
Supernus Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) 400 and 600 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 high doses of SPN-812 in adolescents (12-17 years old) with ADHD
Detailed Description:
This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group study to assess the efficacy and safety of SPN-812 as a monotherapy for the treatment of adolescents 12-17 years old 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?: