A Single Centre. Parallel-Group, Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial on Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (500mg-1500mg per day) and Safety profile
研究概览
简要总结
Pain remains the most debilitating symptom for adult patients suffering from complex regional pain syndrome (CRPS). Most CRPS patients gain little to no relief from current painkillers. The purpose of this study is to evaluate the efficacy and safety of ethosuximide in search of much-needed adjunctive therapy to relieve the pain and suffering associated with CRPS.
详细描述
This is a single centre, parallel-group, double-blind, randomized, placebo-controlled pilot clinical trial for adults suffering from complex regional pain syndrome (CRPS).
Twelve (12) subjects diagnosed with CRPS will be enrolled and randomized to receive orally, either ethosuximide or placebo. If the maximum trial medication dosage (1500mg) is reached, the subject will be in the study for a maximum of 10 weeks from screening (Clinic Visit 1) to the end of the drug cessation period. The minimum period a subject could complete the study would be 4 weeks presuming they were not previously on any disallowed drugs and only found the 500mg dose tolerable.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥18 years old;
- •Diagnosis of Complex Regional Pain Syndrome (CRPS) using International Association for the Study of Pain criteria >6 months;
- •Normal liver function (AST level <3x normal level);
- •Normal kidney function (serum creatinine <133µmol/L);
- •Full blood count, haematocrit >38%;
- •Willing and able to give informed consent and of completing study questionnaires;
- •Stable (no change in past two months) but suboptimal pain pharmacotherapy (i.e. additional pain control felt by patient and physician to be necessary);
- •Able to attend research centre according to the visit schedule;
- •Women of child-bearing potential must be using a reliable form of contraception i.e. oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or abstinence.
排除标准
- •Optimal response to opioids, antidepressants, anticonvulsants or anti- inflammatory medications;
- •Any history or indication of kidney or liver disease;
- •Any history of alcohol abuse;
- •Presence of diabetes;
- •Subjects taking other anti-epileptic drugs, including gabapentin, pregabalin, topiramate, phenytoin, carbamazepine, and oxcarbazepine;
- •Pregnancy (a serum bHCG pregnancy test will be performed as part of the initial blood panel);
- •Known or suspected allergy to succinimides, ethosuximide, methsuximide (Celontin®), phensuximide;
- •Any history of mental illness or disorder, which in the investigators opinion, interferes with the subjects ability to accurately report treatment response;
- •Participation in other clinical trial in the 30 days prior to enrolment.
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
干预措施: Ethosuximide (Drug)
结局指标
主要结局
Maximum tolerated dose (500mg-1500mg per day) and Safety profile
时间窗: up to 10 weeks
Primary outcomes will consist of the dose attained during the study and the safety (adverse event) profile. Maximum timeframe on study drug is 6 weeks. Adverse events will be collected up to one month after the trial period ends.
次要结局
- Pain Intensity Scores on the Visual Analogue Scale (VAS)(up to 7 weeks)
- Pain Intensity Scores on the Numerical Rating Scale (NRS)(up to 5 weeks)
- Neuropathic Pain Symptom Inventory (NPSI)(up to 7 weeks)
- Short Form 12v2 (SF-12v2)(up to 7 weeks)
- Short Form McGill Pain Questionnaire (SF-MPQ)(up to 7 weeks)