NL-OMON54093招募中3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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 start >6 months ago, complement inhibitors and Fc receptor
- •inhibitors start > 6 months ago and a stable regimen for 3 months.
排除标准
- •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 3,4-DAP 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.
研究者
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