EUCTR2017-004777-14-IT进行中（未招募）1 期
ong term safety study of amifampridine phosphate in patients with MuSK antibody positive and AChR antibody positive myasthenia gravis patients - MSK-003
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Participated in the MSK-002 study
- •- Willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures
- •- Female patients of childbearing potential must have a negative pregnancy test (urine human chorionic gonadotropin [HCG] at the end of MSK-002 study); and must practice an effective, reliable contraceptive regimen during the study and for up to 30 days following discontinuation of treatment
- •- Ability to participate in the study based on overall health of the patient and disease prognosis, as applicable, in the opinion of the Investigator; and able to comply with all requirements of the protocol, including completion of study questionnaires
- •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 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Epilepsy and currently on medication
- •- Clinically significant abnormalities in 12 lead ECG, in the opinion of the Investigator
- •- Breastfeeding or pregnant at Screening or planning to become pregnant at any time during the study
- •- Intolerable amifampridine-related side effects
- •- Treatment with an investigational drug (other than amifampridine) or device while participating in this study
- •- Any medical condition that, in the opinion of the Investigator, might interfere with the patient’s participation in the study, poses an added risk for the patient, or confound the assessment of the patient
研究者
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