NCT00917839Unknown2 期
Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
研究概览
简要总结
This study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definitive multiple sclerosis according to Mc Donald criteria
- •clinical isolated syndrome according to Mc Donald criteria
- •Expanded Disability Status Scale Score 0-5
- •Pre-treatment with interferon beta 1a (Avonex) since at least 2 months before inclusion
排除标准
- •relapse within 30 days prior to randomisation
- •steroid pulse therapy within 30 days prior to randomisation
- •pregnancy or poor contraception
- •contraindication for lamotrigine
- •depressive symptoms
- •drugs with possible interaction with lamotrigine according to instruction leaflet
- •other medical relevant conditions but multiple sclerosis
- •clinically relevant laboratory results
- •contraindication for MRI
- •missing informed consent
研究组 & 干预措施
lamotrigine
Experimental
7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral
干预措施: lamotrigine (Drug)
Placebo
Placebo Comparator
300mg Mannitol with 2% Aerosil
干预措施: lamotrigine (Drug)
结局指标
主要结局
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
时间窗: 12 months
Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.
时间窗: 6 months, 12 months
次要结局
- relapse rate(12 months)
- Expanded disability status score(12 months)
- Fatigue Severity Score(12 months)
- N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy(6 months)
研究者
研究点 (1)
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