NCT01074619已完成3 期
Effects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pace Auditory Serial Addition Test(P.A.S.A.T)
研究概览
简要总结
The purpose of this study is to determine if memantine is effective in the treatment on cognitive disorders of Relapsing - Remitting multiple sclerosis. m
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Remitting Multiple Sclerosis defined by Mc Donald et al., 2001
- •Patient with authorised immunomodulator treatment or oral immunosuppressive therapy during more than three months: Bétâ Interferon, glatiramer acetate, azathioprine, methotrexate, mycophenolate mofetil, treatment by monoclonal antibody I.V. or anti-VLA4, natalizumab (Tysabri)
- •Patient having benefited, possibly, of following treatments : mitoxantrone, cyclophosphamide, cyclosporine, general-purpose immunoglobulins, only if the treatment is ended more of 6 months before the inclusion.
- •EDSS score ≤ 5.5
- •DRS score ≥ 130
- •PASAT 3s score > 15 and < median / control subjects according to 2 age brackets, sex, school level.
- •Signed the informed consent form.
- •Effective contraception for women in age to procreate
排除标准
- •Progressive form MS
- •MS relapse of less of 4 weeks.
- •IV or oral corticoid treatment in the month preceding the screening
- •Medicinal treatments or non medicinal in cognitive or psychology-stimulant aim in the 3 months before the screening
- •Tumoral form MS visible in the MRI.
- •Depressive syndrome (MADRS score > 19).
- •Quite other diagnosed psychiatric pathology
- •Known allergy or quite contraindication in memantin : renal or hepatic insufficiency, turned out epileptic disease, treatment by ketamine, amantadin, dextromethorphan, L-Dopa, dopaminergic agonist, barbituric, neuroleptic, 3,4-diaminopyridine, lithium, cimetidine, ranitidine, procainamide, quinine, nicotine, hydrochlorthiazide and ally, phenytoin, modafinil.
- •Recent treatment (less of 4 weeks) by antidepressants and/or anxiolytics.
- •Pregnancy or feeding.
- •Minor or Major "protected by the law" patient
- •Uncontrolled diet.
- •Patient having benefited of one psychometric assessment(including in particular tests planned in the protocol) since less of one year.
研究组 & 干预措施
1
Experimental
Memantine
干预措施: Memantine (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pace Auditory Serial Addition Test(P.A.S.A.T)
时间窗: +1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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