Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
NCT ID: NCT04239469
Last Updated: 2020-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
44 participants
INTERVENTIONAL
2020-01-15
2020-09-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KL16-012
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.
KL16-012
Standardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD
Placebo
Patients will use a liquid placebo identical to the active principle in both appearance and taste.
Placebo
Placebo
Interventions
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KL16-012
Standardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FIQ \> 39 (refractary symptoms)
* Previous use of at least 2 conventional pharmacotherapies
Exclusion Criteria
* History of major psychiatric or cardiovascular diseases
* Pregnancy
* Urine THC (+)
18 Years
65 Years
FEMALE
No
Sponsors
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Knop Laboratorios
INDUSTRY
Responsible Party
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Other Identifiers
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PC003DT
Identifier Type: -
Identifier Source: org_study_id
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