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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04239469
• Other study ID #: PC003DT
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 15, 2020
• Est. completion date: September 15, 2020

Study information

• Verified date: January 2020
• Source: Knop Laboratorios
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: September 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 (+)

Related Conditions & MeSH terms

• Cannabis
• Fibromyalgia
• Marijuana Abuse
• Myofascial Pain Syndromes

Intervention

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
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Knop Laboratorios

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in plasma cytokines	Quantitative ELISA measurements of plasma levels of IL-6, IL-8, CXCL5, CXCL6, MCP-2, LAP TGFß-1 and TNFa	Baseline to 12 weeks