Improving symptomatic treatment with pyridostigmine and amifampridine: a randomized double-blinded,placebo controlled crossover trial in patients with myasthenia gravis (IMPACT-MG) - Pyridostigmine and amifampridine for myasthenia gravis

eiden University Medical Center0 个研究点目标入组 24 人开始时间: 2022年7月12日最近更新: 2024年3月4日

适应症

试验速览

暂无简介。

•1. Age >18 years
•2. AChR positive myasthenia gravis (ocular or generalized)
•3. Current use of pyridostigmine
•4. MGFA Clinical Classification I-IV
•5. Receiving a stable dose of MG treatment (other than pyridostigmine). If applicable:
•a. A stable steroid regimen for 1 month
•b. Nonsteroidal immunosuppressants:
•i. Azathioprine, mycophenolate mofetil, cyclosporine or other nonsteroid immunosuppressive agents start > 3 months ago and a stable regimen for 1 month.
•ii. Rituximab, complement inhibitors and Fc receptor inhibitors start > 6 months ago and a stable regimen for 3 months.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 17
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•1. Use of intravenous immunoglobulin or plasma exchange <4 weeks
•2. Thymectomy < 6 months, or thymectomy (expected) to take place during the trial
•3. Use of other AChE inhibitors than pyridostigmine
•4. Pregnancy, lactation or intention to become pregnant during the study
•5. Treatment with amifampridine is contraindicated. Contraindications include a history of epilepsy, uncontrolled asthma, inherited QT syndrome / a prolonged QT interval (as indicated by ECG), any drug known to cause QTc-prolongation, concomitant use of sultopride, a known hypersensitivity reaction to the active substance or to any of the excipients.
•6. The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to undergo the tests needed for the study, or is unable to give informed consent for participation in the study.
•7. The investigator can exclude patients for this trial which are deemed not suitable for any reason.

发起方

eiden University Medical Center