Trial | NCT04239469  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    44
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 Started
Jan 15
2020
Anticipated
Primary Completion
Jun 15
2020
Anticipated
Study Completion
Sep 15
2020
Anticipated
Last Update
Jan 27
2020

Drug KL16-012 [tetrahydrocannabinol, cannabidiol (Epidiolex)]

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

Drug Placebo

Placebo

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.

Placebo Placebo Comparator

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

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 (+)
No Results Posted