Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359899
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-25
Brief Title:
A Study to Evaluate the Efficacy Safety and Tolerability of Oral AK0901 in Children With ADHD
Sponsor:
Shanghai Ark Biopharmaceutical Co Ltd
Organization:
Shanghai Ark Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase III Study to Investigate the Efficacy Safety and Tolerability of Oral Administered AK0901 Capsules in Children Aged 6-12 Years Old With Attention Deficit Hyperactivity Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 is a Phase 3 multicenter dose-optimized double-blind randomized placebo-controlled study designed to evaluate the efficacy safety and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity DisorderADHD
Detailed Description:
The study consists of an approximately 28-day screening period a 28-day double-blind treatment period and a follow-up period for 52 days
During the screening period all subjects must sign an informed consent form and complete all assessment items at the screening visit prior to the screening Study drug is started within 28 days of signing the informed consent form
During the double-blind treatment period all eligible subjects are randomized 11 to receive AK0901 or placebo once daily for 4 weeks During the first week all subjects are given a starting dose of 392 mg78 mg AK0901 or matching placebo from the second week the dose drug can be increased or decreased or maintained at the original dose level at weekly follow-up depending on tolerability and optimal individual dose response at the investigators discretion
After the last dose in the double-blind treatment period subjects will enter a 5 2 day follow-up period for safety assessments The primary analysis will be performed after all subjects have completed the study
During the screening period all subjects must sign an informed consent form and complete all assessment items at the screening visit prior to the screening Study drug is started within 28 days of signing the informed consent form
During the double-blind treatment period all eligible subjects are randomized 11 to receive AK0901 or placebo once daily for 4 weeks During the first week all subjects are given a starting dose of 392 mg78 mg AK0901 or matching placebo from the second week the dose drug can be increased or decreased or maintained at the original dose level at weekly follow-up depending on tolerability and optimal individual dose response at the investigators discretion
After the last dose in the double-blind treatment period subjects will enter a 5 2 day follow-up period for safety assessments The primary analysis will be performed after all subjects have completed the study
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?:
True
Is an FDA AA801 Violation?:
None