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

• Sponsor: Knop Laboratorios (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04239469
• Collaborator: (none)
• Enrollment: 44
• Arms: 2
• Anticipated Duration (Months): 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia; Cannabis	Drug: KL16-012; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
• Anticipated Study Start Date: Jan 15, 2020
• Anticipated Primary Completion Date: Jun 15, 2020
• Anticipated Study Completion Date: Sep 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Fibromyalgia Impact Questionnaire (FIQ) score [Baseline to 12 weeks]

   Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.

Secondary Outcome Measures

1. Change in Fibromyalgia Impact Questionnaire (FIQ) score [Baseline to 2 weeks]

   Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.

2. Change in Fibromyalgia Impact Questionnaire (FIQ) score [Baseline to 4 weeks]

   Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.

3. Change in Fibromyalgia Impact Questionnaire (FIQ) score [Baseline to 8 weeks]

   Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.

4. Change in Insomnia Severity Index (ISI) score [Baseline to 2 weeks]

   Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.

5. Change in Insomnia Severity Index (ISI) score [Baseline to 4 weeks]

   Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.

6. Change in Insomnia Severity Index (ISI) score [Baseline to 8 weeks]

   Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.

7. Change in Insomnia Severity Index (ISI) score [Baseline to 12 weeks]

   Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.

8. Change in pain Visual Analog Scale (VAS) score [Baseline to 2 weeks]

   Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.

9. Change in pain Visual Analog Scale (VAS) score [Baseline to 4 weeks]

   Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.

10. Change in pain Visual Analog Scale (VAS) score [Baseline to 8 weeks]

    Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.

11. Change in pain Visual Analog Scale (VAS) score [Baseline to 12 weeks]

    Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.

12. Changes in plasma cytokines [Baseline to 12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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 (+)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Knop Laboratorios

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Knop Laboratorios
• ClinicalTrials.gov Identifier: NCT04239469
• Other Study ID Numbers: PC003DT
• First Posted: Jan 27, 2020
• Last Update Posted: Jan 27, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Knop Laboratorios: cannabis; fibromyalgia; phytocannabinoids; cannabinoid
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes

Study Results

No Results Posted as of Jan 27, 2020