EUCTR2015-000263-14-GB进行中（未招募）不适用
Mycophenolate Treatment for Longstanding Complex Regional Pain Syndrome (MYPS I) - MYPS I
Walton Centre NHS Foundation Trust0 个研究点目标入组 12 人开始时间: 2015年2月12日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Diagnosis of Complex Regional Pain Syndrome I or II according to Budapest research criteria (appendix 2)
- •2.Disease duration of >2 years, and a mean pain intensity on an 11-point (0-10) Numeric Rating Scale (NRS) over the first fourteen daily entries after screening of 5 or higher (and no single daily pain intensity value below 5, a minimum of 13 valid scores need to be available).
- •3.Failure to respond (poor efficacy or unacceptable side effects) to drugs recommended for the treatment of neuropathic pain, including pregabalin or gabapentin, a tricyclic antidepressant, and mild and strong opioids (where not contraindicated or refused by the patient).
- •4.Previous pain-physiotherapy (where not contraindicated or refused)
- •5.Willingness to confirm the use of adequate birth control while on the trial will be required in pre-menopausal women without evidence for an inability to become pregnant.
- •6.Willingness to not start any other treatment for CRPS until the end of active treatment.
- •7.Age 18 years and above.
- •8.Blood antibodies against varicella zoster confirming immunity against varicella infection (expected present in 90% of the population), to mitigate the risk of new varicella injection under immunosuppression.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1.Other significant chronic pains, which in the view of the study doctor may make assessment of the pain arising from CRPS difficult.
- •2.If the patient recently started a new therapy for CRPS, which in the view of the study doctor may change the patient’s pain level during the time of participation in the trial.
- •3.Unstable medical conditions.
- •4.Pregnant or breastfeeding patients.
- •5.Receiving mycophenolate for other reasons, or previously tried mycophenolate.
- •6.Concomitant systemic treatment with other immunosuppressant drugs.
- •7.Ongoing drug or alcohol misuse.
- •8.Psychiatric or mental health disorder, which could in the judgment of the study doctor interfere with successful study participation.
- •9.Unwillingness or inability to complete daily diaries, or inability to understand the questionnaires being used.
- •10.Cancer other than basal cell carcinoma within the last 5 years. However those patients who have received definite treatment, such as curative surgery more than 6 months ago, with no known recurrence can be included.
- •11.Specific contraindications to mycophenolate.
- •12.Renal failure or serum creatinine greater than 1.5 times the upper limit of normal at screening.
- •13.Liver failure, any blood dyscresia.
- •14.Any medical condition, which in the opinion of the investigator would make it unsafe for the patient to participate or which would interfere with assessment of the outcome measures.
- •15.Participation in another interventional trial within 3 month before randomization. Participation in non-interventional studies is not a reason for exclusion.
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