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

Knop Laboratorios44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fibromyalgia Cannabis

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (+)

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Baseline to 12 weeks