BridgeMD
Tests treatment safety and results for Focal Seizures
Official title A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
ClinicalTrials.gov ID: NCT07233239
What this study is testing
What is CBD-OS?
CBD-OS is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for focal seizures.
Also referred to as GWP42003-P, JZP926.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Cannabidiol oral solution (CBD-OS) is approved in the US for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or Tuberous sclerosis complex (TSC) in patients 1 year of age and older. This study will assess the efficacy and safety of CBD-OS in participants aged 12 to 75 years for the treatment of focal-onset seizures (FOS).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 75
You may be able to join if
- Participants are eligible to be included in the main study only if all of the following criteria apply:
- Participant has a documented diagnosis of focal epilepsy according to the ILAE Classification of Epilepsy, 2017, characterized by focal seizure types...
- Participant is currently treated with at least 1, but no more than 4, antiseizure medications on a stable regimen.
- Participant is aged 12 to 75 years old, inclusive, at Screening. Participants are excluded from the study if any of the following criteria apply:
- Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the how well it works measures, in the...
See the full eligibility criteria
- Participants are eligible to be included in the main study only if all of the following criteria apply:
- Participant has a documented diagnosis of focal epilepsy according to the ILAE Classification of Epilepsy, 2017, characterized by focal seizure types with typical interictal/ictal EEG findings (eg, history of an EEG...
- Participant is currently treated with at least 1, but no more than 4, antiseizure medications on a stable regimen.
- Participant is aged 12 to 75 years old, inclusive, at Screening. Participants are excluded from the study if any of the following criteria apply:
- Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the how well it works measures, in the opinion of the investigator.
- Has clinically significant unstable medical condition(s), other than epilepsy.
- 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 or Item 5 on the C-SSRS or is considered at risk of...
- 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...
- Presence of only nonmotor focal aware seizures or primary generalized epilepsies.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- La Jolla, California, United States
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Chicago, Illinois, United States
- Bethesda, Maryland, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Edison, New Jersey, United States
- New Brunswick, New Jersey, United States
- Hawthorne, New York, United States
- Charlotte, North Carolina, United States
- Raleigh, North Carolina, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Memphis, Tennessee, United States
- Austin, Texas, United States
- El Paso, Texas, United States
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; La Jolla, California, United States; New Haven, Connecticut, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Savannah, Georgia, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.