Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919407
Status:
RECRUITING
Last Update Posted:
2023-06-26
First Post:
2023-06-06
Brief Title:
Pyridostigmine and Amifampridine for Myasthenia Gravis
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
IMproving Symptomatic Treatment With Pyridostigmine and Amifampridine a Randomized Double-blinded Placebo Controlled Crossover Trial in Patients With Myasthenia Gravis IMPACT-MG
Status:
RECRUITING
Status Verified Date:
2023-06
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:
IMPACT-MG
Brief Summary:
A randomized double-blind placebo controlled crossover intervention study evaluating the effect of pyridostigmine part 1 and amifampridine part 2 in Myasthenia Gravis MG
Detailed Description:
In the first part of the study patients who are currently using pyridostigmine will be randomly allocated to one of two consecutive treatment periods in which patients either first receive placebo and then their usual dose of pyridostigmine or vice versa Each treatment period lasts 5 days with a 2-day wash-out period between each treatment period Measurements will be performed at every last day of a treatment period day 5 and day 12
In the second part of the study the effect of two doses of amifampridine as add-on to pyridostigmine will be studied Patients will be randomly assigned to either one of three treatment sequences 1 amifampridine 30 mg - amifampridine 60 mg - placebo or 2 amifampridine 60 mg - placebo - amifampridine 30 mg or 3 placebo - amifampridine 30 mg - amifampridine 60 mg Again each treatment period consists of 5 days and will be separated by a 2-day wash-out period Measurements will be performed at every last day of treatment day 19 day 26 and day 33
Patients will have the option to participate in a substudy to characterize the pharmacokinetics PK and pharmacodynamics PD of amifampridine in AChR positive MG patients
In the second part of the study the effect of two doses of amifampridine as add-on to pyridostigmine will be studied Patients will be randomly assigned to either one of three treatment sequences 1 amifampridine 30 mg - amifampridine 60 mg - placebo or 2 amifampridine 60 mg - placebo - amifampridine 30 mg or 3 placebo - amifampridine 30 mg - amifampridine 60 mg Again each treatment period consists of 5 days and will be separated by a 2-day wash-out period Measurements will be performed at every last day of treatment day 19 day 26 and day 33
Patients will have the option to participate in a substudy to characterize the pharmacokinetics PK and pharmacodynamics PD of amifampridine in AChR positive MG patients
Study Oversight
Has Oversight DMC:
None
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?:
None