Pyridostigmine and Amifampridine for Myasthenia Gravis (IMPACT-MG)
Pyridostigmine and Amifampridine for Myasthenia Gravis (IMPACT-MG)
ClinicalTrials.gov ID: NCT05919407
Sponsor: Leiden University Medical Center
Information provided by: Martijn R. Tannemaat, MD PhD, Leiden University Medical Center (Responsible Party)
Last Update Posted: 2023-06-26
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.
OFFICIAL TITLE
IMproving Symptomatic Treatment With Pyridostigmine and Amifampridine: a Randomized Double-blinded, Placebo Controlled Crossover Trial in Patients With Myasthenia Gravis (IMPACT-MG)
INTERVENTION / TREATMENT
Drug: Pyridostigmine
Drug: Amifampridine (base) with modified release
Drug: Placebo
Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2023-03-22 |
| Primary Completion (Estimated) | 2024-09-22 |
| Study Completion (Estimated) | 2024-09-22 |
| Enrollment (Estimated) | 24 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | NL78666.058.21 |