Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-13 @ 7:05 PM
Study NCT ID:
NCT02858908
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2016-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Tideglusib in Adolescent and Adult Patients With Myotonic Dystrophy
Sponsor:
AMO Pharma Limited
Organization:
Study Overview
Official Title:
A Single-Blind, Phase 2 Study To Evaluate The Safety And Efficacy Of Tideglusib 400mg Or 1000mg For The Treatment Of Adolescent And Adult Congenital And Juvenile-Onset Myotonic Dystrophy
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT07119775
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether Tideglusib is safe and efficacious in the treatment of adolescents and adults with congenital and juvenile-onset Myotonic Dystrophy. The pharmacokinetics of tideglusib and its primary metabolite will also be investigated.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-000067-16 | EUDRACT_NUMBER | None | View |