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

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 Overview

• Status: Unknown
• Conditions: Fibromyalgia; Cannabis
• Intervention / Treatment: Drug: Placebo; Drug: KL16-012

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 (+)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Knop Laboratorios

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2020
• Primary Completion (Anticipated): June 15, 2020
• Study Completion (Anticipated): September 15, 2020

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: fibromyalgia; cannabis; cannabinoid; phytocannabinoids
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: PC003DT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No