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

Knop Laboratorios

Status and phase: Unknown; Phase 2

Conditions: Fibromyalgia; Cannabis

Treatments: Drug: Placebo; Drug: KL16-012

Study type: Interventional

Funder types: Industry

Identifiers

NCT04239469

PC003DT

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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 (+)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

44 participants in 2 patient groups, including a placebo group

KL16-012

Active Comparator group

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.

Treatment:

Drug: KL16-012

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo