Epidiolex for Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on how Epidiolex/Epidyolex, a medication often used for seizures, affects health outcomes during pregnancy and up to a year after birth. The study has two parts: one for individuals who are pregnant and currently taking the medication, and another for those who took it during a past pregnancy. Ideal participants are those who used Epidiolex/Epidyolex around the time of conception or during pregnancy. The trial aims to gather important insights into the medication's safety and effects during pregnancy.
As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients, offering valuable insights for those considering participation.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It focuses on participants who have been exposed to Epidiolex during pregnancy.
What is the safety track record for Epidiolex/Epidyolex?
Research has shown that Epidiolex, a type of cannabidiol (CBD), is generally safe for both children and adults. However, concerns exist about its use during pregnancy. Animal studies have found that it can lead to higher rates of embryo death and lower birth weights.
In human studies, Epidiolex is usually well-tolerated, but some side effects, such as pneumonia, have been reported, particularly when combined with other medications. These findings are crucial when considering its safety during pregnancy. While the FDA has approved Epidiolex for certain conditions, its effects during pregnancy require careful review based on current evidence.12345Why are researchers excited about this trial?
Researchers are excited about investigating Epidiolex/Epidyolex during pregnancy because it offers a unique approach compared to traditional anti-seizure medications. Unlike standard epilepsy treatments, which often rely on synthetic compounds, Epidiolex is derived from cannabidiol (CBD), a compound found in cannabis plants. This natural origin may offer a different safety profile, especially important for pregnant individuals concerned about medication effects on fetal development. By exploring the impact of Epidiolex during pregnancy, researchers hope to uncover insights into its safety and efficacy, potentially offering an alternative for managing seizures without the typical risks associated with other anti-seizure drugs.
What evidence suggests that Epidiolex/Epidyolex is effective during pregnancy?
Research has shown that Epidiolex, a type of cannabidiol (CBD), effectively treats certain conditions like seizures in epilepsy. It is approved for managing seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. However, information on its safety during pregnancy remains limited. This trial includes two arms: the Retrospective Pregnancy arm, for participants exposed to Epidiolex before or during pregnancy who are no longer pregnant at enrollment, and the Prospective Pregnancy arm, for those pregnant at enrollment. A pregnancy exposure registry tracks outcomes for women using Epidiolex while pregnant, aiding in gathering more information. Although some studies suggest potential risks with cannabis use during pregnancy, Epidiolex is a specific, purified form of CBD. More research is needed to fully understand its effects during pregnancy.12567
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
Pregnancy Monitoring
Participants are monitored for maternal complications and pregnancy outcomes during gestation
Neonate and Infant Follow-up
Participants' neonates and infants are monitored for major congenital malformations and other events of interest
What Are the Treatments Tested in This Trial?
Interventions
- Epidiolex
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is no longer pregnant at the time of study enrollment.
Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is pregnant at the time of study enrollment.
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
Citations
Pregnancy Surveillance Program of Patients Exposed to ...
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their ...
EPIDIOLEX (cannabidiol) oral solution - accessdata.fda.gov
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as EPIDIOLEX, during pregnancy.
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clinicaltrials.gov
clinicaltrials.gov/study/NCT06113237?term=AREA%5BInterventionSearch%5D(cannabidiol)&rank=6Pregnancy Surveillance Program of Patients Exposed to ...
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their ...
Willingness of pregnant and postpartum women who use ...
... prenatal cannabis use and offspring outcomes are mixed. A recent study on prenatal cannabis use and maternal pregnancy outcomes reported that the prenatal ...
Articles The impact of oral cannabis consumption during ...
Our results show that oral consumption of either CBD or THC oil during pregnancy in mice results in harm to the developing fetus and causes behavioural changes ...
In utero exposure to cannabidiol disrupts select early-life ...
Overall, these data indicate that gestational CBD is deleterious to early life behaviors in a sex-specific manner. In humans, gestational cannabis negatively ...
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 ...
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