Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.

Conditions
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Fibromyalgia, Cannabis

Intervention / Treatment
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* Drug: KL16-012
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of fibromyalgia based on ACR 2010 criteria FIQ > 39 (refractary symptoms) Previous use of at least 2 conventional pharmacotherapies Exclusion Criteria: History of substance use disorder History of major psychiatric or cardiovascular diseases Pregnancy Urine THC (+)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KL16-012<br>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. | Drug: KL16-012<br>* Standardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD<br>* Other names: Cannabiol;|
| Placebo Comparator: Placebo<br>Patients will use a liquid placebo identical to the active principle in both appearance and taste. | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fibromyalgia Impact Questionnaire (FIQ) score | Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fibromyalgia Impact Questionnaire (FIQ) score | Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms. | Baseline to 2 weeks | 
| Change in Fibromyalgia Impact Questionnaire (FIQ) score | Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms. | Baseline to 4 weeks | 
| Change in Fibromyalgia Impact Questionnaire (FIQ) score | Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms. | Baseline to 8 weeks | 
| Change in Insomnia Severity Index (ISI) score | Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia. | Baseline to 2 weeks | 
| Change in Insomnia Severity Index (ISI) score | Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia. | Baseline to 4 weeks | 
| Change in Insomnia Severity Index (ISI) score | Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia. | Baseline to 8 weeks | 
| Change in Insomnia Severity Index (ISI) score | Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia. | Baseline to 12 weeks | 
| Change in pain Visual Analog Scale (VAS) score | Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain. | Baseline to 2 weeks | 
| Change in pain Visual Analog Scale (VAS) score | Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain. | Baseline to 4 weeks | 
| Change in pain Visual Analog Scale (VAS) score | Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain. | Baseline to 8 weeks | 
| Change in pain Visual Analog Scale (VAS) score | Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain. | Baseline to 12 weeks | 
| Changes in plasma cytokines | Quantitative ELISA measurements of plasma levels of IL-6, IL-8, CXCL5, CXCL6, MCP-2, LAP TGFβ-1 and TNFα | Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cannabis, fibromyalgia, phytocannabinoids, cannabinoid