ACTRN12612001160820终止2 期
Phase IIb Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Trial to determine the safety and efficacy of Vitamin D3 in preventing the risk of MS in Patients with a first demyelinating event.
MS Research Australia0 个研究点目标入组 202 人开始时间: 2012年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •For inclusion in this study, a participant must meet the following criteria:
- •* aged between 18 and 65 years old inclusive
- •* have a first isolated, well-defined, uni- or multi-focal first demyelinating event (FDE)
- •* be able to receive first dose of study drug within 135 days of FDE symptom onset
- •* have an MRI brain scan that is supportive of demyelinating disease (Paty A or Paty B criteria) OR have at least one >5mm diameter T2/Flair brain lesion which must be in a periventricular, callosal, subcortical U-fibre or posterior fossa location AND must have at least one spinal cord lesion.
- •* an EDSS between 0 - 6.5 (inclusive)
- •* be able to give informed consent and sign the informed consent form
- •* be willing to avoid open-label vitamin D supplementation and external serum vitamin D testing for the duration of the study
- •* be willing to avoid use of sunbeds
- •* not have received any prior disease modifying treatment for MS other than glucocorticoids
- •* be willing to avoid treatment with beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, or other chemotherapy agent specifically for demyelinating disease until recurrent disease activity occurs (ie the primary endpoint is met)
- •* be able and willing to comply with all study procedures including MRI scanning as per protocol
- •* be willing to use effective contraceptive methods for the duration of the study and at least 6 months following.
排除标准
- •Any of the following conditions will exclude a participant from the study:
- •* currently pregnant or breastfeeding
- •* documented or likely prior neurological event consistent with a diagnosis of clinically definite MS
- •* treatment with beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, or other chemotherapy agent specifically for demyelinating disease
- •* a second clinical demyelinating event prior to randomisation
- •* a history of primary hyperparathyroidism or any other condition causing hypercalcaemia
- •* a history of sarcoidosis
- •* a history of renal calculi
- •* a history of treated osteoporosis or any other condition requiring treatment with calcium, vitamin D, bisposphonates, strontium ranelate, denosumab, raloxifene, calcitriol or teriparetide
- •* hypercalcaemia on screening blood tests
- •* an abnormal eGFR (<60 ml/min/1.73m2), or an elevated uric acid laboratory value (above normal range for the local laboratory used)
- •* concurrent diagnosis of other neurological, psychiatric or other disease which, in the opinion of the investigator, could impair capacity to provide informed consent, interfere with study compliance, or impair the participant’s ability to comply with the study protocol
- •* current enrolment in another interventional trial
- •* any contraindication to MRI scanning or intravenous Gadolinium including:
- •a) cardiac pacemaker
- •b) cardiac defibrillator
- •c) metal fragments in the eye
- •d) any other non-MRI compatible medical device/implant or medical condition
- •e) previous reaction to Gadolinium
- •f) severe claustrophobia.
研究者
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