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Tests treatment safety and results for Focal Epilepsy
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?
RAP-219 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for 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
- This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.
- 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; laboratory or ECG finding that...
- 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; laboratory or ECG finding that would increase participant risk or should otherwise exclude the...
- 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's taking place
- 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 - 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?
Study sites include 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(s). Enter your location above to see the nearest site and check your eligibility.
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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.