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

Primary Purpose

Fibromyalgia, Cannabis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
KL16-012
Placebo
Sponsored by
Knop Laboratorios
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring cannabis, fibromyalgia, phytocannabinoids, cannabinoid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 (+)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    KL16-012

    Placebo

    Arm Description

    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.

    Patients will use a liquid placebo identical to the active principle in both appearance and taste.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    Changes in plasma cytokines
    Quantitative ELISA measurements of plasma levels of IL-6, IL-8, CXCL5, CXCL6, MCP-2, LAP TGFβ-1 and TNFα

    Full Information

    First Posted
    January 5, 2020
    Last Updated
    January 22, 2020
    Sponsor
    Knop Laboratorios
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04239469
    Brief Title
    Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
    Official Title
    Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 15, 2020 (Anticipated)
    Primary Completion Date
    June 15, 2020 (Anticipated)
    Study Completion Date
    September 15, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Knop Laboratorios

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia, Cannabis
    Keywords
    cannabis, fibromyalgia, phytocannabinoids, cannabinoid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    KL16-012
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will use a liquid placebo identical to the active principle in both appearance and taste.
    Intervention Type
    Drug
    Intervention Name(s)
    KL16-012
    Other Intervention Name(s)
    Cannabiol
    Intervention Description
    Standardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Change in Fibromyalgia Impact Questionnaire (FIQ) score
    Description
    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 Outcome Measure Information:
    Title
    Change in Fibromyalgia Impact Questionnaire (FIQ) score
    Description
    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
    Title
    Change in Fibromyalgia Impact Questionnaire (FIQ) score
    Description
    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
    Title
    Change in Fibromyalgia Impact Questionnaire (FIQ) score
    Description
    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
    Title
    Change in Insomnia Severity Index (ISI) score
    Description
    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
    Title
    Change in Insomnia Severity Index (ISI) score
    Description
    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
    Title
    Change in Insomnia Severity Index (ISI) score
    Description
    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
    Title
    Change in Insomnia Severity Index (ISI) score
    Description
    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
    Title
    Change in pain Visual Analog Scale (VAS) score
    Description
    Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.
    Time Frame
    Baseline to 2 weeks
    Title
    Change in pain Visual Analog Scale (VAS) score
    Description
    Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.
    Time Frame
    Baseline to 4 weeks
    Title
    Change in pain Visual Analog Scale (VAS) score
    Description
    Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.
    Time Frame
    Baseline to 8 weeks
    Title
    Change in pain Visual Analog Scale (VAS) score
    Description
    Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.
    Time Frame
    Baseline to 12 weeks
    Title
    Changes in plasma cytokines
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 (+)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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