NCT00623415终止2 期
Multicentric, Prospective, Double Blind, Randomized/Stratified, Placebo-controlled Pilot-study for Evaluation of Safety and Efficacy of Flupirtine add-on to Interferon-β1b on Neurodegeneration 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
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)
研究概览
简要总结
Flupirtine, a non-opioid analgesic drug, that has been shown to have additional neuroprotective functions, is given twice daily as an oral medication in patients with relapsing remitting multiple sclerosis over a period of 12 months. Neuroprotection is assessed by magnetic resonance imaging, magnetic resonance spectroscopy, optical coherence tomography, and clinical examination.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Relapsing-remitting MS according to the revised McDonald-Criteria (2005)
- •EDSS ≤ 4.0
- •Stable treatment with Interferon-β1b for at least 6 months
- •Sufficient birth control (Pearl-Index <1)
排除标准
- •Any other MS-course than RRMS
- •Clinically relevant gastrointestinal disease
- •Clinically relevant pulmonary, cardiological, infectious or CNS-disease
- •Clinically relevant disease of liver or bile system, pathological value for transaminases, gamma-GT or bilirubin.
- •Hepatitis (except uncomplicated hepatitis A with complete remission
- •Clinically relevant dysfunction of kidneys (creatinine >180 µmol/l) or bone marrow (HB < 8.5 g/dl, WBC < 2.5/nl thrombocytes < 125/nl)
- •Myasthenia gravis
- •Oral anticoagulation (phenprocoumon)
- •Treatment with carbamazepine or paracetamol
- •Drug or alcohol abuse
- •Pregnancy or lactation period
- •Treatment at any time before or during study with complete lymphoradiation, monoclonal antibodies (e.g. anti-CD4, Campath 1H, natalizumab), mitoxantrone, cyclophosphamide, cyclosporin, azathioprine
- •Treatment within 6 months before randomization with any other immunomodulatory substance than interferon-β1b or intravenous methylprednisolone
研究组 & 干预措施
Placebo
Placebo Comparator
placebo + interferon beta 1b
干预措施: Placebo (Drug)
Verum
Active Comparator
flupirtine + interferon beta 1b
干预措施: Flupirtine (Drug)
结局指标
主要结局
Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)
时间窗: 12 months
次要结局
- Number of new and total gadolinium(Gd)-enhancing lesions(12 months)
- Cerebral atrophy (brain parenchymal fraction)(12 months)
- Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC))(12 months)
- Retinal nerve fiber layer thickness, assessed by Optical coherence tomography(12 months)
研究者
研究点 (4)
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