RECRUITINGPhase 2INTERVENTIONAL
A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, 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.
Who Should NOT Join This Trial:
- 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 patient from participation, as assessed by Investigator
- Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, 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.
Exclusion Criteria:
* 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 patient from participation, as assessed by Investigator
* Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
Treatments Being Tested
DRUG
RAP-219
Participants will receive one RAP-219 0.125 mg capsule daily for 3 days followed by one 0.25mg tablet RAP-219 daily for 28 days, then one 0.75mg tablet daily for the remainder of the treatment period.
Locations (7)
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Comprehensive Epilepsy Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennsylvania - Department of Neurology
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States