Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523400
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-03
Brief Title:
The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multi-Center Study to Investigate the Efficacy and Safety of Once Daily Mexiletine PR During 26 Weeks of Treatment in Patients With Myotonic Dystrophy Type 1 and Type 2 Phase 3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Randomized Double-blind Placebo-Controlled Multi-Center Study to Investigate the Efficacy and Safety of Once Daily Mexiletine PR During 26 Weeks of Treatment in Patients with Myotonic Dystrophy Type 1 and Type 2 HERCULES study
Detailed Description:
This is a multicenter randomized double-blind parallel-group placebo-controlled study intended to evaluate the efficacy and the safety of mexiletine PR in patients with myotonic dystrophy type 1 and type 2 DM1 and DM2 The study will consist of a 4- week screening period and a 26-week treatment phase with patient visits at screening baseline Weeks 1 2 14 and 26 Eligible patients will be randomized to mexiletine or placebo in a 11 ratio Approximately 80 DM1 patients 40 active 40 placebo are planned to be enrolled For the purpose of sample size re-estimation an interim analysis will be conducted when a total of 40 patients in total completeearly terminate the study
In addition 16 DM2 patients are planned to be enrolled sub-group - 8 active 8 placebo
In addition 16 DM2 patients are planned to be enrolled sub-group - 8 active 8 placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None