NL-OMON42310已完成2 期
A randomized, double-blind, placebo-controlled, cross-over study to assess the effects of fampridine on eye movements and nerve conduction and function in patients with multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO) - Fampridine in MS patients with INO
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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 64（—）
入选标准
- •1. Male and female patients 18 years or more of age;
- •2. Diagnosis of multiple sclerosis according to the revised McDonald (2005) criteria;
- •3. A disease duration > 1 year as defined by a diagnosis of MS at least one year prior to inclusion in the study;
- •4. Clinically stable disease > 30 days;
- •5. Subject shows evidence of INO by quantitative neuro-ophthalmological criteria;
- •6. Subject is able to understand the demands of the protocol, has had any questions answered and has voluntarily signed the informed consent prior to any study procedures; and
- •7. Subject is otherwise in good health, based on complete medical history and physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests.
排除标准
- •1. Subject is a pregnant female (as determined by a urine pregnancy test), a lactating female, or a female of child-bearing potential, not sterilized and not using one of the following methods of birth control: oral or injectable contraceptive agent, implantable contraceptive device, or barrier method;
- •2. The neuro-ophthalmological examination demonstrates significant impairment of eye-movements due to cerebellar or other pathology which may infer with reliable testing of an INO;
- •3. Inability of a subject to maintain good visual fixation;
- •4. Subject has a prior history or current presentation of seizure;
- •5. Subject has a creatinine clearance less than 80 mL/min, calculated by Cockroft-Gault equation;
- •6. Subject has known allergy to fampridine;
- •7. Subject has any contraindication of MRI;
- •8. The subject has any medical condition, including psychiatric disease that might interfere with the interpretation of the results or with the conduct of the study;
- •9. Subject has a history of drug or ethanol abuse within the past year;
- •10. A positive urine drug screen;
- •11. Subject has a history of ischemic heart disease;
- •12. Concomitant use of fampridine with medicinal products that are inhibitors or substrates of organic cation transporter 2 (OCT2) such as cimetidine, carvedilol, propanolol and metformin;
- •13. Treatment with another investigational drug within 3 months prior to screening or having participated in more than 4 investigational drug studies within 1 year prior to screening; and/or
- •14. The subject has abnormal clinical laboratory values or an abnormal ECG, without approval of the study investigator.
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