Cannabidiol for Seizures
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have uncontrolled seizures while on their current antiseizure medications, suggesting you may continue them.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have uncontrolled seizures despite being on one or more antiseizure medications, suggesting you may continue your current treatment.
What data supports the idea that Cannabidiol for Seizures is an effective drug?
The available research shows that Cannabidiol (CBD) is effective in reducing seizures for people with certain types of epilepsy, like Lennox-Gastaut syndrome and Dravet syndrome. In studies, patients who took CBD along with their usual treatment had fewer seizures compared to those who did not add CBD. For example, in some trials, patients who received CBD had better outcomes in terms of seizure frequency than those who only received their current treatment without CBD. This suggests that CBD can be a helpful addition to existing treatments for these conditions.12345
What data supports the effectiveness of the drug Cannabidiol (CBD) for treating seizures?
Research shows that Cannabidiol (CBD), specifically Epidiolex, can reduce seizures in patients with difficult-to-treat epilepsy, including conditions like Lennox-Gastaut syndrome and Dravet syndrome. Studies found that adding CBD to existing treatments led to better seizure control compared to treatments without CBD.12345
What safety data is available for CBD in treating seizures?
Safety data for cannabidiol (CBD), marketed as Epidiolex, includes findings from various studies. Common side effects reported are somnolence and diarrhea. There are known drug interactions, such as with lithium, which can lead to toxicity. Long-term studies show that CBD is generally well-tolerated in children with treatment-resistant epilepsy, with a study retention rate of 77% at one year. Adverse events decreased over time in a prospective study, indicating improved tolerability.46789
Is cannabidiol (CBD) safe for treating seizures?
Cannabidiol (CBD), also known as Epidiolex, has been studied for safety in treating seizures, especially in conditions like Dravet syndrome and Lennox-Gastaut syndrome. Common side effects include sleepiness and diarrhea, and it may interact with other medications, such as lithium, potentially causing issues like excessive sleepiness and coordination problems. However, many patients continue to use it safely with improved seizure control.46789
Is the drug Cannabidiol promising for treating seizures?
How does the drug cannabidiol differ from other treatments for seizures?
Cannabidiol (CBD) is unique because it is derived from the cannabis plant and works by interacting with the TRPV1 receptor, which is involved in controlling nerve cell activity. Unlike traditional anti-seizure medications, CBD is specifically approved for use in certain severe epilepsy syndromes like Dravet and Lennox-Gastaut, and it is often used in combination with other drugs like clobazam.24101112
What is the purpose of this trial?
This trial tests a medication called GWP42003-P in children under 2 years old who have severe seizure disorders like TSC, LGS, or DS. The study will last over a year and will check if the medication is safe, how it moves through the body, and if it helps reduce seizures. These conditions often don't respond well to usual treatments, so new options are needed. Cannabidiol (pharmaceutical) is approved by the FDA for the treatment of seizures associated with DS, Lennox-Gastaut syndrome, and tuberous sclerosis complex in patients ≥1 year of age.
Eligibility Criteria
This trial is for children under 2 years old with TSC, LGS, or DS who have seizures not well-controlled by current medications. They must be diagnosed according to specific guidelines and their caregivers should consent and comply with study requirements. Children with certain health issues or hypersensitivity to cannabinoids are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adjunctive GWP42003-P with a 2-week titration period followed by flexible dose optimization for up to 52 weeks
Taper
Participants undergo a 10-day taper period to safely reduce medication dosage
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- GWP42003-P
Find a Clinic Near You
Who Is Running the Clinical Trial?
GW Research Ltd
Lead Sponsor
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