Focal Epilepsy study: RAP-219
Official title A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
ClinicalTrials.gov ID: NCT07219407
What this study is testing
What is RAP-219?
An investigational oral medication being studied for refractory focal epilepsy.
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
- The study aims to find out how safe RAP‑219 is over a long period and whether it helps control seizures in people whose epilepsy does not respond well to other treatments.
- Who it's for
- Adults who have focal epilepsy that has not responded to other medications.
- What's involved
- Participants will receive the investigational drug RAP‑219 and will have regular clinic visits and seizure monitoring to track safety and seizure activity.
- Time commitment
- The study lasts many months, with scheduled visits throughout the treatment period to monitor health and seizure frequency.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable side effects, per Investigator.
- Diagnosis of refractory focal epilepsy
- Stable RNS(c) system settings
- A demonstrated history of compliance with RNS(c) system data interrogation and upload
- Good overall health other than focal epilepsy, per Investigator.
You likely can't join if
- Known of hypersensitivity to RAP-219
- Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem
- Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
See the full eligibility criteria
- Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable side effects, per Investigator.
- Diagnosis of refractory focal epilepsy
- Stable RNS(c) system settings
- A demonstrated history of compliance with RNS(c) system data interrogation and upload
- Good overall health other than focal epilepsy, per Investigator.
- BMI ≥ 18 kg/m\^2 and ≤ 45 kg/m\^2
- Willing and able to adhere to all aspects of the protocol.
- Known of hypersensitivity to RAP-219
- Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem
- Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
The study team makes the final eligibility decision.
Where it is enrolling
- Boise, Idaho, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
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, but 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, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boise, Idaho, United States; Rochester, Minnesota, United States; New York, New York, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.