Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431256
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-22
Brief Title:
Ph3 Multicenter 3wk RDBPC Efficacy Safety PK Study of Evening Dosed MPH HCl ER Capsules HLD200 in Children 4-5 Yr With ADHD
Sponsor:
Ironshore Pharmaceuticals and Development Inc
Organization:
Ironshore Pharmaceuticals and Development Inc
Study Overview
Official Title:
Phase 3 Multicenter 3-Week Fixed-dose Randomized Double-blind Placebo-controlled Parallel-group Efficacy Safety and Pharmacokinetic Study of Evening Dosed Methylphenidate Hydrochloride Extended-Release Capsules HLD200 in Children Aged 4 to 5 Years With ADHD
Status:
RECRUITING
Status Verified Date:
2024-05
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 safety and pharmacokinetics of HLD200 20 mg and 40 mg in children aged 4 to 5 years with ADHD
Detailed Description:
This is a multicenter 3 week fixed dose randomized double-blind placebo-controlled parallel group study to evaluate the efficacy safety and pharmacokinetics of HLD200 20 mg and 40 mg in children aged 4 to 5 years with ADHD
Participants will be screened for eligibility for up to 4 weeks Eligible participants will be treated with study medication for 3 weeks followed by a 2 week safety follow-up following the end of study treatment The total duration of the study is up to 9 weeks A single pharmacokinetic PK sample will be taken from each participant in a prespecified PK sampling window at visit 5 for population PK analysis
A total of 168 participants 56 per treatment arm will be randomized at Visit 2
Participants will be screened for eligibility for up to 4 weeks Eligible participants will be treated with study medication for 3 weeks followed by a 2 week safety follow-up following the end of study treatment The total duration of the study is up to 9 weeks A single pharmacokinetic PK sample will be taken from each participant in a prespecified PK sampling window at visit 5 for population PK analysis
A total of 168 participants 56 per treatment arm will be randomized at Visit 2
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