FibromyalgiaPhase 2NCT04239469
Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
A Phase 2 study testing KL16-012 in people with Fibromyalgia and Cannabis, run by Knop Laboratorios.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia, Cannabis
- What is being tested?
- KL16-012
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2020to 15 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of fibromyalgia based on ACR 2010 criteria
- FIQ > 39 (refractary symptoms)
- Previous use of at least 2 conventional pharmacotherapies
Who cannot join
- History of substance use disorder
- History of major psychiatric or cardiovascular diseases
- Pregnancy
- Urine THC (+)
About this study
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
- Fibromyalgia, Cannabis
- Being tested
- KL16-012, Placebo
- Keywords
- cannabis, fibromyalgia, phytocannabinoids, cannabinoid
- Medical subject headings
- Fibromyalgia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KL16-012Drug
Also called Cannabiol
Standardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: KL16-012 |
| Placebo | Placebo comparator | Patients will use a liquid placebo identical to the active principle in both appearance and taste. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fibromyalgia Impact Questionnaire (FIQ) score
Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.
Measured: Baseline to 12 weeks
Secondary outcomes (12)
Change in Fibromyalgia Impact Questionnaire (FIQ) score
Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.
Measured: Baseline to 2 weeks
Change in Fibromyalgia Impact Questionnaire (FIQ) score
Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.
Measured: Baseline to 4 weeks
Change in Fibromyalgia Impact Questionnaire (FIQ) score
Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.
Measured: Baseline to 8 weeks
Change in Insomnia Severity Index (ISI) score
Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.
Measured: Baseline to 2 weeks
Change in Insomnia Severity Index (ISI) score
Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.
Measured: Baseline to 4 weeks
Change in Insomnia Severity Index (ISI) score
Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.
Measured: Baseline to 8 weeks
Change in Insomnia Severity Index (ISI) score
Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.
Measured: Baseline to 12 weeks
Change in pain Visual Analog Scale (VAS) score
Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.
Measured: Baseline to 2 weeks
Change in pain Visual Analog Scale (VAS) score
Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.
Measured: Baseline to 4 weeks
Change in pain Visual Analog Scale (VAS) score
Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.
Measured: Baseline to 8 weeks
Change in pain Visual Analog Scale (VAS) score
Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.
Measured: Baseline to 12 weeks
Changes in plasma cytokines
Quantitative ELISA measurements of plasma levels of IL-6, IL-8, CXCL5, CXCL6, MCP-2, LAP TGFβ-1 and TNFα
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 Jan 2020 (estimated)
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Knop Laboratorios
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239469
- Sponsor's protocol ID
- PC003DT
- Status last verified
- Jan 2020
- First submitted
- 5 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
- ClinicalTrials.gov ID
- NCT04239469
- Acronym / sponsor ID
- PC003DT
- Conditions
- Fibromyalgia, Cannabis
- Keywords
- cannabis, fibromyalgia, phytocannabinoids, cannabinoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Knop LaboratoriosIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2020 (estimated)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KL16-012 | Active comparator | Drug: KL16-012Patients 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 | Drug: PlaceboPatients will use a liquid placebo identical to the active principle in both appearance and taste. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of fibromyalgia based on ACR 2010 criteria
- FIQ > 39 (refractary symptoms)
- Previous use of at least 2 conventional pharmacotherapies
Key exclusion criteria (4 listed)
- History of substance use disorder
- History of major psychiatric or cardiovascular diseases
- Pregnancy
- Urine THC (+)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KL16-012Also: CannabiolStandardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD | Drug | KL16-012 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in Fibromyalgia Impact Questionnaire (FIQ) score
Time frame: Baseline to 12 weeks
Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.
12 secondary outcomes
Change in Fibromyalgia Impact Questionnaire (FIQ) score
Time frame: Baseline to 2 weeks
Change in Fibromyalgia Impact Questionnaire (FIQ) score
Time frame: Baseline to 4 weeks
Change in Fibromyalgia Impact Questionnaire (FIQ) score
Time frame: Baseline to 8 weeks
Change in Insomnia Severity Index (ISI) score
Time frame: Baseline to 2 weeks
Change in Insomnia Severity Index (ISI) score
Time frame: Baseline to 4 weeks
Change in Insomnia Severity Index (ISI) score
Time frame: Baseline to 8 weeks
Change in Insomnia Severity Index (ISI) score
Time frame: Baseline to 12 weeks
Change in pain Visual Analog Scale (VAS) score
Time frame: Baseline to 2 weeks
Change in pain Visual Analog Scale (VAS) score
Time frame: Baseline to 4 weeks
Change in pain Visual Analog Scale (VAS) score
Time frame: Baseline to 8 weeks
Change in pain Visual Analog Scale (VAS) score
Time frame: Baseline to 12 weeks
Changes in plasma cytokines
Time frame: Baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KL16-012 in people with Fibromyalgia and Cannabis, run by Knop Laboratorios.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fibromyalgia Impact Questionnaire (FIQ) score (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.