Cannabidiol for Partial Seizures
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a cannabidiol oral solution (CBD-OS) to determine its effectiveness in reducing focal-onset seizures, which begin in one area of the brain. The goal is to assess the effectiveness and safety of CBD-OS for individuals experiencing these seizures. Individuals diagnosed with focal epilepsy and currently taking 1 to 4 antiseizure medications may be suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
No, you don't have to stop taking your current medications. Participants must be on a stable regimen of 1 to 4 antiseizure medications to join the trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that cannabidiol oral solution (CBD-OS) is generally safe. It is already approved for treating seizures in conditions like Lennox-Gastaut syndrome and Dravet syndrome. This approval indicates extensive testing and effectiveness for seizures, with a strong safety record.
In studies, participants have used CBD-OS long-term without major issues. Common side effects include fatigue, diarrhea, and loss of appetite, which are usually mild. Since this study is in the early stages, the main goal is to ensure safety for people with focal-onset seizures. Its existing approval for other seizure types suggests a positive safety profile.12345Why do researchers think this study treatment might be promising for seizures?
Most treatments for partial seizures rely on traditional antiepileptic drugs that stabilize nerve activity in the brain, but cannabidiol oral solution (CBD-OS) works differently. CBD-OS is derived from cannabidiol, a compound found in cannabis plants, and it offers a new mechanism by potentially interacting with the endocannabinoid system to reduce seizure frequency. Researchers are excited about CBD-OS because it offers a novel approach that could provide relief for patients who don't respond well to conventional medications, and it also has a favorable side effect profile compared to some existing options.
What evidence suggests that Cannabidiol Oral Solution might be an effective treatment for focal-onset seizures?
Research has shown that Cannabidiol Oral Solution (CBD-OS), which participants in this trial will receive, can effectively reduce seizures. In earlier studies, CBD treatment led to a 54%–77% decrease in focal seizures. Long-term results demonstrated that CBD continued to help reduce seizures over time. Many caregivers observed a significant drop in seizure frequency, with 93% planning to continue the treatment due to its effectiveness. While CBD-OS is already approved for some seizure conditions, these findings suggest it could also be promising for treating focal-onset seizures.678910
Are You a Good Fit for This Trial?
This trial is for individuals aged 12 to 75 with focal epilepsy, characterized by specific seizure types and EEG patterns. They must be on a stable regimen of 1-4 antiseizure medications. Those using cannabis products or unwilling to abstain, with only nonmotor seizures, primary generalized epilepsies, significant medical conditions other than epilepsy, suicidal behavior or ideation, hypersensitivity to cannabinoids or sesame oil are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive open-label CBD-OS as an adjunctive treatment to reduce the frequency of focal seizures
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol Oral Solution (CBD-OS)
Trial Overview
The study tests Cannabidiol oral solution (CBD-OS) in participants with focal-onset seizures (FOS). It aims to evaluate the efficacy and safety of CBD-OS which is already approved for certain seizure disorders in patients over one year old.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants who will receive open-label CBD-OS.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jazz Pharmaceuticals
Lead Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Jazz Pharmaceuticals Research UK Ltd.
Collaborator
Citations
Cannabidiol in the Treatment of Epilepsy: A Focused Review ...
Favorable outcomes were found in the 10 and 20 mg/kg CBD groups during the treatment period with a median percentage reduction from baseline in the frequency of ...
Long-term Effectiveness of Cannabidiol (CBD) Against ...
Four-year EAP results demonstrated that CBD was associated with sustained seizure improvement in TRE.
real-world outcomes of cannabidiol cbd in treatment-resistant ...
CBD treatment was associated with a median 54%–77% reduction from baseline in focal seizures and 54%–75% reduction in total seizures during 12- ...
Caregiver-reported outcomes with real-world use of ...
Overall, 93% of caregivers reported planning to continue CBD treatment, primarily because of reduced seizure burden but also because of improvements in ...
Trial of Cannabidiol for Drug-Resistant Seizures in the ...
This trial showed that cannabidiol reduced the frequency of convulsive seizures among children and young adults with the Dravet syndrome over a ...
EPIDIOLEX (cannabidiol) oral solution - accessdata.fda.gov
Safety and effectiveness of EPIDIOLEX for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome have been established in ...
Long‐term efficacy and safety of cannabidiol in patients ...
Open‐label CBD treatment was associated with sustained seizure reduction through 144 weeks, with a consistent safety profile in patients with ...
Frequently Asked Questions | EPIDIOLEX® (cannabidiol)
EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or ...
Cannabidiol Oral Solution | Anti-Seizure Medicine
Cannabidiol oral solution is approved for use to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, ...
Epidyolex 100 mg/ml oral solution
Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with ...
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