Cannabis for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether cannabis, specifically CBD (a compound from the cannabis plant), can help prevent chronic migraine headaches. Researchers will divide participants into three groups: one will receive a higher dose of CBD, another a lower dose, and the third a placebo (a pill with no active ingredient). The study seeks individuals who have experienced migraines for at least a year and have tried at least two other migraine treatments without success or with adverse effects. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
You can continue taking your current migraine preventative medications if the dose has been stable for at least 3 months before the study and will remain unchanged during the study. However, certain treatments like nerve blocks and some medications are not allowed during the study period.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that CBD, the main ingredient in the trial treatment, is generally safe. Research indicates that both children and adults usually tolerate it well. Common side effects include sleepiness, reduced appetite, diarrhea, and fatigue. Reports have noted increased liver enzymes, typically with higher doses or when combined with certain other medications.
The FDA has approved CBD for treating some types of seizures, but the doses and uses in this trial differ. This approval suggests that CBD has undergone thorough safety evaluations. Overall, while some side effects may occur, CBD has a history of safe use in various situations.12345Why are researchers excited about this trial's treatments for chronic migraines?
Researchers are excited about using CBD for migraine prevention because it offers a new approach compared to traditional treatments like triptans, beta-blockers, or anti-seizure medications. Unlike these options, which often focus on treating symptoms or preventing migraines through vascular or neurological pathways, CBD targets the endocannabinoid system, potentially addressing migraines from a different angle. Additionally, CBD is derived from cannabis, which is of interest for its anti-inflammatory and pain-relieving properties. This could mean fewer side effects and a more natural alternative for those suffering from migraines.
What evidence suggests that this trial's treatments could be effective for chronic migraine headaches?
Research has shown that CBD (cannabidiol) may help treat certain conditions, particularly epilepsy. Studies have found that CBD can significantly reduce seizures in people with epilepsy, suggesting its effectiveness as a treatment. In this trial, participants will receive either a higher dose of CBD, a lower dose of CBD, or a placebo. While CBD is primarily known for aiding with seizures, it might also help with migraines due to its anti-inflammatory properties. Although direct research on CBD for migraines is limited, its potential to ease pain and reduce inflammation makes it a promising option for managing chronic migraines.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either lower dose CBD, higher dose CBD, or placebo. The dose is increased every 4 days until the target dose is reached.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including MSQ, MIDAS, HIT-6, GAD-7, PHQ-9, and PSQI scores.
What Are the Treatments Tested in This Trial?
Interventions
- CBD
- Placebo
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
The higher dose CBD group will start with CBD capsules 10 mg OD and will increase every 4 days until on a target dose of 200 mg OD.
The lower dose CBD group will start with CBD capsules 10 mg OD, then increase the dose every 4 days until on the target dose of 100 mg OD.
CBD is already approved in United States, European Union, Canada for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Citations
Real‐world data on cannabidiol treatment of various epilepsy ...
Our study highlights that CBD has an antiseizure effect comparable to other antiseizure medications with a positive safety profile independent of the epilepsy ...
Real-world, long-term evaluation of the tolerability and ...
In the 3-year open-label extension trial (OLE) for Epidiolex®, the retention rate at 1 year of therapy was 81%, followed by 69% at year 2, and 65% at year 3 [5] ...
effectiveness of cannabidiol in patients with rare epilepsies ...
At Week 12, CBD was associated with a median reduction from baseline of 58.1% and 51.8% in convulsive and total seizures, respectively, which ...
Cannabidiol Drugs Clinical Trial Outcomes and Adverse ...
The patients in the treatment group reported significant reduction in the number of seizures, with over 90% of patients reporting at least a 25% reduction in ...
Clinical Study Results | EPIDIOLEX® (cannabidiol)
EPIDIOLEX significantly reduced seizures in people living with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) for whom ...
Safety and Tolerability | EPIDIOLEX® (cannabidiol)
EPIDIOLEX was found to have a consistent safety profile in children and adults. Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and ...
Adverse events of epidiolex: A real-world drug safety ...
Epidiolex mainly includes drowsiness, reduced appetite, diarrhea, increased transaminases, fatigue, rash, sleep disorders, and infections.
EPIDIOLEX (cannabidiol) oral solution - accessdata.fda.gov
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying ...
The current understanding of the benefits, safety, and ... - PMC
By contrast, a significant amount of safety evaluation data for CBD has been obtained recently from pre-clinical and clinical studies of the CBD therapeutic ...
Epidyolex Data Sheet
In vitro data have demonstrated that cannabidiol inhibits CYP2C19, which may cause increased plasma concentrations of medicines that are metabolised by this ...
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