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

NCT04239469 | Unknown Phase 2

• 1 other identifier: PC003DT
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibromyalgia; Cannabis

Keywords

cannabis; fibromyalgia; phytocannabinoids; cannabinoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in Fibromyalgia Impact Questionnaire (FIQ) score

  Baseline to 2 weeks

• Change in Fibromyalgia Impact Questionnaire (FIQ) score

  Baseline to 4 weeks

• Change in Fibromyalgia Impact Questionnaire (FIQ) score

  Baseline to 8 weeks

• Change in Insomnia Severity Index (ISI) score

  Baseline to 2 weeks

• Change in Insomnia Severity Index (ISI) score

  Baseline to 4 weeks

Study Arms (2)

KL16-012

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

KL16-012 DRUG

Standardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD

Also known as: Cannabiol

KL16-012

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of fibromyalgia based on ACR 2010 criteria
• FIQ \> 39 (refractary symptoms)
• Previous use of at least 2 conventional pharmacotherapies

You may not qualify if:

• History of substance use disorder
• History of major psychiatric or cardiovascular diseases
• Pregnancy
• Urine THC (+)

Sponsors & Collaborators

• Knop Laboratorios: lead

MeSH Terms

Conditions

Fibromyalgia; Marijuana Abuse

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 27, 2020
• Study Start: January 15, 2020
• Primary Completion: June 15, 2020
• Study Completion: September 15, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share