NL-OMON39601已完成2 期
Ephedrine as add-on therapy for patients with myasthenia gravis - Ephedrine for MG
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
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. Adult patient with a diagnosis of generalised MG based on
- •a) Clinical signs or symptoms suggestive of generalised myasthenia gravis (for example, slowly progressive fluctuating muscle weakness in specific muscle groups); and
- •b) A positive serologic test for acetylcholine receptor (AChR) antibodies ;2. Treatment with pyridostigmine, and / or low dose (max. 15 mg/day) prednisone and / or other immunosuppressive drugs does not (or no longer) adequately improve myasthenic symptoms.
- •The dosage of pyridostigmine, prednisone and other immunosuppressive drugs need to have been stable for at least 6 weeks prior to the trial.
排除标准
- •1. Purely ocular myasthenia (i.e. myasthenic symptoms that are limited to the extraocular muscles, such as ptosis and diplopia)
- •2. Treatment with ephedrine is contraindicated or was not tolerated in the past.
- •Contraindications include myocardial ischemia (angina pectoris and / or myocardial infarction), any cardiac arrhythmia, angle-closure glaucoma, current treatment by a psychologist or psychiatrist, current hypertension (defined as 2 measurements >= 140 / 90 mm Hg), poorly regulated diabetes mellitus, inherited QT syndrome or a prolonged QT interval (as indicated by ECG), prostatic hypertrophy and thyrotoxicosis. Patients with relevant drug interactions (MAO inhibitors, alpha and beta blockers) are also excluded.
- •3. Reliance upon medium-high dose prednisone (> 15 mg/day) and recent (< 3 months) or regular intravenous immunoglobulin (ivIG) or plasma exchange therapy. This excludes steroid-sparing therapy such as azathioprine and excludes supportive therapy such as any form of physical therapy.
- •These treatments are not exclusion criteria for the open label extension phase.
- •4. Myasthenic crisis in the past 3 months
- •5. Thymectomy in the past 6 months, or thymectomy (expected) to take place during the trial
- •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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