Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT02829827
Status:
TERMINATED
Last Update Posted:
2019-09-17
First Post:
2016-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)
Sponsor:
UCB Biopharma S.P.R.L.
Organization:
Study Overview
Official Title:
An Open-label Adaptive Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Radiprodil in Subjects With Drug-resistant Infantile Spasms
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After reviewing the feasibility and projected completion date of the study, UCB has made the decision to stop the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms
Detailed Description:
The study is divided into 3 parts:
Part A - exploratory, Part B - confirmatory, Part C - open label extension
Part A - exploratory, Part B - confirmatory, Part C - open label extension
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-002107-26 | EUDRACT_NUMBER | None | View |