Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 44
- 主要终点
- Change in Fibromyalgia Impact Questionnaire (FIQ) score
研究概览
简要总结
A double blind randomized placebo controlled trial in 44 women with fibromyalgia and persistent symptoms in spite of use of conventional pharmacotherapy, will be performed in the city of Valparaiso. Patients will be randomized to either placebo or active principle and be followed for 3 months. Assesment of efficacy and safety will be done by measurement of changes in their Fibromyalgia Impact Questionnaire (FIQ) score, Insomnia Severity Index (ISI) score, pain Visual Analogue Scale (VAS) score, plasma cytokine levels and detection of adverse effects.
The active principle will be a standardized extract of cannabis sativa containing 1 milligram of tetrahydrocannabinol (THC) and 0.45 milligrams cannabidiol (CBD) per drop.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia based on ACR 2010 criteria
- •FIQ > 39 (refractary symptoms)
- •Previous use of at least 2 conventional pharmacotherapies
排除标准
- •History of substance use disorder
- •History of major psychiatric or cardiovascular diseases
- •Pregnancy
- •Urine THC (+)
研究组 & 干预措施
KL16-012
Patients will use a liquid standardized extract of cannabis sativa. Each drop will contain 1 mg of THC and 0.45 mg of CBD. Administration will be sublingual, while dosing will begin at 3 drops per day and be escalated to 15 drops per day by week 5 according to an escalation chart.
干预措施: KL16-012 (Drug)
Placebo
Patients will use a liquid placebo identical to the active principle in both appearance and taste.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Fibromyalgia Impact Questionnaire (FIQ) score
时间窗: Baseline to 12 weeks
Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.
次要结局
- Change in Fibromyalgia Impact Questionnaire (FIQ) score(Baseline to 8 weeks)
- Change in Insomnia Severity Index (ISI) score(Baseline to 12 weeks)
- Changes in plasma cytokines(Baseline to 12 weeks)
- Change in pain Visual Analog Scale (VAS) score(Baseline to 12 weeks)