Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786990
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2021-03-01
Brief Title:
Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD
Sponsor:
Supernus Pharmaceuticals Inc
Organization:
Supernus Pharmaceuticals Inc
Study Overview
Official Title:
A Phase IV Open-Label Flexible-Dose Safety Trial Evaluating SPN-812 Administered With Psychostimulants in Children and Adolescents 6 to 17 Years of Age With Attention-DeficitHyperactivity Disorder ADHD
Status:
COMPLETED
Status Verified Date:
2024-04
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:
ADHD
Brief Summary:
This open label flexible-dose study evaluating the safety and efficacy of SPN-812 administered with psychostimulants in children and adolescents 6 to 17 years of age with Attention-DeficitHyperactivity Disorder ADHD
Detailed Description:
This is an open-label multicenter flexible-dose safety study of SPN-812 in pediatric patients 6-17 years of age diagnosed with ADHD when administered with a FDA-approved medication psychostimulant in the treatment of Attention-DeficitHyperactivity Disorder ADHD in pediatric subjects Participants will be screened for eligibility for up to 4 weeks and heshe will continue to take their prescribed psychostimulant ADHD medication during that time Following the screening period eligible subjects will receive SPN-812 with their current psychostimulant treatment for ADHD for 8 weeks For the first 4 weeks of treatment subjects will take SPN-812 dose in the morning AM dosing and for the last 4 weeks of treatment subjects will take SPN-812 dose in the evening PM dosing The total duration of the study between the screening visit and the end of the treatment periodend of study EOS visit is up to 12 weeks
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