Trials / Unknown
UnknownNCT04239469
Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- Knop Laboratorios · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2020-01-15
- Primary completion
- 2020-06-15
- Completion
- 2020-09-15
- First posted
- 2020-01-27
- Last updated
- 2020-01-27
Source: ClinicalTrials.gov record NCT04239469. Inclusion in this directory is not an endorsement.