Ignite Creation Date:
2024-05-06 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03247556
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2017-08-09
Brief Title:
Evaluation of SPN-812 Viloxazine Extended-release Capsule High Dose in Adolescents With ADHD
Sponsor:
Supernus Pharmaceuticals Inc
Organization:
Supernus Pharmaceuticals Inc
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:
None
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?:
None