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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KL16-012 | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | Patients will use a liquid placebo identical to the active principle in both appearance and taste. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KL16-012 | Drug | Standardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Placebo | Drug | Placebo |
|
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 |
| D009422 |
| Nervous System Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |