Multicenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 8
- 主要终点
- Disability scale of Kurtzke EDSS score
研究概览
简要总结
The investigators plan to carry out a multicenter randomized clinical trial and MRI study of high-dose oMP (1250mg/day for 3 days) versus lower-high dose oMP (625mg/day for 3 days) and demonstrated that lower-high dose of oMP is as effective as a higher-high dose of oMP in acute relapse of multiple sclerosis (MS). If it is shown, our purpose is to promote this therapeutic regimen because it is safer for the patient (less adverse effects) and less costly to the healthcare system.
详细描述
DESIGN: Phase IV clinical trial, multicentre, randomized and double blind, active drug controlled and parallel groups. Patients will be randomised to a high dose of oMP vs a lower-high dose of oral Methylprednisolone (oMP).
SETTING: 9 MS Units from 9 hospitals of the public health system with extensive experience in treating patients with MS and design and participation in clinical trials.
PROCEDURES:
After signing the informed consent, the inclusion and exclusion criteria specific to the study will be checked. The diagnostic test will take place prior to administration of study medication and will include medical history, neurological examination (EDSS measurement) taking of vital signs (blood pressure, heart rate and body temperature) and MRI. Concomitant medication will be checked. Patients will be instructed about the requirements during the study.
The trial medication will be provided to the patient in the medical office (day 1 of the study), where the patient will remain until the intake. This action will be repeated the following 2 days. The latency period from the beginning of the relapse until the start of treatment will be registered. The questionnaires of tolerance will be completed.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing-remitting MS (Mc Donald criteria 2010) regardless being under immunomodulatory treatment
- •EDSS (previous to relapse) between 0 and 5
- •MS relapse of moderate intensity (EDSS increase from 1 to 2.5 points) or severe intensity (EDSS increase > 3 points)
- •If EDSS previous relapse is available:
- •optic neuritis, myelitis or brainstem relapse: the EDSS should increase of 1 point in visual, pyramidal or brainstem system function
- •relapse in other location or uncertain location: the EDSS should increase at least 1 point
- •If EDSS previous relapse is not available:
- •optic neuritis, myelitis or brainstem relapse: the visual, pyramidal or brainstem system function should be > 2 points.
- •relapse in other location or uncertain location: EDSS should be > 2 points
- •Recent clinical relapse onset (<15 days) without fever
- •One month of clinical stability prior to relapse
- •Signed informed consent
- •Capacity to ingest the medication.
排除标准
- •Doubts about the diagnosis of multiple sclerosis
- •First episode of inflammatory neurological disease
- •Secondary progressive MS or primary progressive MS
- •Symptoms with lasted less than 24 hours of evolution
- •Any degree of subjective or objective remission
- •Treatment with corticosteroids during the previous 30 days
- •Patients with immunosuppressive treatment (azathioprine, mitoxantrone, cyclophosphamide) or Natalizumab or Fingolimod
- •Pregnancy or breastfeeding women or women of childbearing potential not using contraceptive measures
- •Diseases with a contraindication of treatment with corticosteroids
- •History of serious adverse reaction or hypersensitivity to drugs related to study medication
- •Patients who could not be regular MRI, not collaborators or who requires anesthesia.
- •Lactose intolerance
- •Patients with allergies to contrast used in MRI
- •Patients with renal impairment
研究组 & 干预措施
oMP 1250 mg: Group A
Methylprednisolone 1250 mg/24h x3 days
干预措施: Methylprednisolone 1250 mg/24h x3 days (Drug)
oMP 625 mg: Group B
Methylprednisolone oral 625 mg/24h x3 days
干预措施: Oral Methylprednisolone 625 mg/24h x3 days (Drug)
结局指标
主要结局
Disability scale of Kurtzke EDSS score
时间窗: up to day 91
次要结局
- Disability scale of Kurtzke EDSS score(Baseline and day 8)
- Adverse events / tolerability(Baseline and day 8)
- The number and volume of active lesions (measured by the T2 or gadolinium enhancement), the number of new active lesions and the percentage of active lesions at baseline that becomes black holes(day -1 and day 29)
- Questionnaire MSQOL-54(Baseline and day 29)
研究者
Cristina Ramo
Cristina Ramo
Germans Trias i Pujol Hospital