EpiFOS Focal-Onset Seizure Study
EpiFOS: A Phase 1b multicenter, open-label study evaluating the safety and efficacy of Cannabidiol Oral Solution (CBD-OS) for the treatment of Focal-Onset Seizures.
NCT07233239
WHAT ARE FOCAL-ONSET SEIZURES?
Focal-onset seizures, or focal seizures (formerly known as partial seizures), are a common type of seizure characterized by excessive abnormal electrical activity originating in one region of the brain. Focal-onset seizures can progress to impact both hemispheres of the brain; when this happens they are called tonic-clonic seizures.
Focal-onset seizures are the most common type of seizure experienced by patients with epilepsy, representing up to 61% of the epilepsy population and affecting millions of individuals globally (Gupta et al, 2017).
** Gupta, S., Ryvlin, P., Faught, E., Tsong, W., & Kwan, P. (2017). Understanding the burden of focal epilepsy as a function of seizure frequency in the United States, Europe, and Brazil. Epilepsia Open, 2(2), 199–213. https:// doi.org/10.1002/epi4.12050
ABOUT THE INVESTIGATIONAL MEDICINE
The trial medication being investigated is cannabidiol oral solution (CBD-OS) which has not been approved by the U.S. Food and Drug Administration for focal-onset seizures. CBD-OS is an oral solution and taken by mouth.
ABOUT THE TRIAL
The EpiFOS study will assess the efficacy of CBD-OS as an adjunctive treatment in reducing the frequency of focal seizures compared to baseline.
Participants must have focal epilepsy and must be currently treated with at least one, but no more than four anti-seizure medications on a stable regimen prior to Screening and have no planned changes to treatment for the duration of the study.
Each participant will be enrolled for up to 27 weeks.
Each participant will be enrolled for up to 27 weeks.
Participation in the EpiFOS study will consist of the following:
At the Screening Visit, individuals will be screened for study eligibility and begin the 6-week baseline period. The purpose of the Baseline Period is to collect information on the frequency and severity of your seizures.
On your Baseline Visit, participants will complete additional assessments and be rechecked for study eligibility followed by administration of study medication.
Open-label Treatment Period (16 weeks): All participants will be assigned to open-label treatment with CBD-OS as follows:
- Titration Period (4 weeks): Participants will start on a lower dose of medication and then over a 4-week period will increase the dose until the optimal maximum dose is achieved.
- Dose Optimization Treatment Period (12 weeks): Participants will be treated with a target CBD-OS maintenance dosage of 20 mg/kg/day following dose titration, with an option to increase up to 25 mg/kg/day based on observed efficacy and safety, if deemed clinically appropriate.
Taper Period (10 days): Participants will be gradually withdrawn from treatment over a 10-day taper period and complete an End of Taper Visit. The Taper Period may be skipped per the physician’s clinical discretion, if the physician does not believe a taper is in the participant’s best interest.
Safety Follow-up Visit (phone call): Participants will have a Safety Follow-up Visit telephone call 28 days after the last dose of CBD-OS is administered.
Estimated Enrollment Approximately 100 participants
KEY ELIGIBILITY CRITERIA
Inclusion criteria
Here are a couple of the key inclusion criteria to participate in the study:
- Must be 12 to 75 years old at time of screening.
- Must have a documented diagnosis of focal epilepsy.
Exclusion criteria
Here are some of the key exclusion criteria:
- Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the efficacy measures, in the opinion of the investigator.
- Has clinically significant unstable medical condition(s), other than epilepsy.
- Has history of status epilepticus in the three months prior to Screening (Visit 1).
- History of suicidal behavior, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to Item 4.
- Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention, such as sesame oil.
- Is currently treated with Epidiolex or received treatment with Epidiolex within 28 days prior to Screening (Visit 1).
- Is currently using or has used recreational or medicinal cannabis, cannabinoid/CBD based medications, products, or supplements (botanical or synthetic) within 28 days prior to Screening (Visit 1) and/or is unwilling to abstain for the duration of the study.
Your study investigator will review ALL the inclusion/exclusion criteria in your screening visit.
STUDY LOCATIONS
For site location, please contact ClinicalTrialDisclosure@jazzpharma.com or visit clinicaltrials.gov (and search "NCT07233239" or click here).
Trial sites listed below are available from clinicaltrials.gov. We do not endorse any specific trial sites.
FREQUENTLY ASKED QUESTIONS (FAQs)
What is a clinical trial?
Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. A clinical trial follows a protocol that has been approved by regulatory agencies and IRBs/ECs.
Will compensation for time and/or travel be available as part of this clinical trial?
Qualified participants will receive payment for their trial-related time and travel.
Can I remove myself from the trial at any time?
Participation is voluntary. You have the right to end your participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements. You should contact the study team with any questions.