Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549400
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-09
Brief Title:
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 Who Have Completed MEX-DM-302 Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 Who Have Completed the MEX-DM-302 Study ATLAS Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This is an open-label extension study intended to evaluate the long-term safety and efficacy of mexiletine PR in patients with myotonic dystrophy type 1 and type 2 DM1 and DM2 who have completed the parent study MEX-DM-302
Detailed Description:
At the completion of the final visit in Study MEX-DM-302 patients who continued to meet the eligibility criteria will be invited to rollover into this open-label study for an additional 18 months All patients who elect to continue into this open-label study will receive active mexiletine no placebo
Mexiletine PR will be started as 167 mg once a day QD treatment regimen The dose will be titrated up at Week 1 to 333 mg and at Week 2 to a maximum dose of 500 mg QD depending on tolerability If unable to tolerate the escalated dose the dose will be reduced by one dose step during the titration period of the study to a maximum tolerated dose Study drug should be taken with food at approximately the same time of the day every day preferably in the morning See Section 7 for further details on reconstitution and dosing titration
Safety assessments include patient- and physician-reported adverse events standard clinical laboratory evaluations physical examinations and vital signs In addition ECG Holter monitors and echocardiogram assessments will be collected to assess cardiac safety during the study
Mexiletine PR will be started as 167 mg once a day QD treatment regimen The dose will be titrated up at Week 1 to 333 mg and at Week 2 to a maximum dose of 500 mg QD depending on tolerability If unable to tolerate the escalated dose the dose will be reduced by one dose step during the titration period of the study to a maximum tolerated dose Study drug should be taken with food at approximately the same time of the day every day preferably in the morning See Section 7 for further details on reconstitution and dosing titration
Safety assessments include patient- and physician-reported adverse events standard clinical laboratory evaluations physical examinations and vital signs In addition ECG Holter monitors and echocardiogram assessments will be collected to assess cardiac safety during the study
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