Recruiting NCT07219407
A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RAP-219.
- Who it may be relevant to
- Registry conditions: Focal Epilepsy, Epilepsy, Refractory Focal Epilepsy, Seizure. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures
Overview
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.
Detailed description
This is a multi-center, open-label study to evaluate the long-term safety, tolerability, pharmacokinetics, pharmacodynamics and antiseizure activity of RAP-219 in adult participants with refractory focal seizures
Interventions
- 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.
Primary outcome measures
- Incidence of treatment-emergent adverse events (TEAEs) [Time frame: From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112]
Secondary outcome measures (12)
- Percent change in clinical seizure frequency [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Clinical seizure 25%, 50%, 75%, and 100% responder proportions [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Change in clinical seizure-free day frequency [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Longest clinical seizure-free interval [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Time to pre-randomization clinical seizure count [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- RNS long episode 30%, 50%, 75% or with 100% responder proportions [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Percent change in RNS long episode frequency [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Change in RNS long episode-free day frequency [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Longest RNS long episode-free interval [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Time to pre-randomization long episode count [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Percent change in RNS estimated electrographic seizure frequency [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Clinical Global Impression of Change (CGI-C) responder count and proportions [Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Consultants in Epilepsy and Neurology, PLLC — Boise
- Mayo Clinic — Rochester
- NYU Langone Comprehensive Epilepsy Center — New York
- Cleveland Clinic Foundation — Cleveland
- University of Pennsylvania - Department of Neurology — Philadelphia
- Vanderbilt University Medical Center — Nashville
- Baylor College of Medicine — Houston
Identifiers
NCT: NCT07219407 · RAP-219-FOS-901