Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
Status:
Not yet recruiting
Trial end date:
2020-09-15
Target enrollment:
Participant gender:
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.