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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGNYU Langone Comprehensive Epilepsy Center
New York, New York, United States
RECRUITINGCleveland Clinic Foundation
Cleveland, Ohio, United States
RECRUITINGUniversity of Pennsylvania - Department of Neurology
Philadelphia, Pennsylvania, United States
RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGIncidence 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
Percent change in clinical seizure frequency
Group median percent change in clinical seizure frequency per 28-day period as reported in a clinical seizure diary
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
Proportion of participants with at least 25%, 50%, 75%, or with 100% reduction in clinical seizure frequency per 28-day period as reported in a clinical seizure diary
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
Group median change in clinical seizure-free day frequency per 28-day period as reported in a clinical seizure diary
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
Duration, in days, of the longest continuous period of clinical seizure-free days per period as reported in a clinical seizure diary
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
Duration, in days, between the beginning of the open-label treatment period and the nth clinical seizure, where n is the number of clinical seizures per 28-day period during the prospective pre-treatment baseline period, as reported in a clinical seizure diary
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
Proportion of participants with at least 30%, 50%, 75%, and 100% reduction in long episodes per 28-day period as recorded by the RNS® System
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
Group median percent change in long episode frequency per 28-day period as recorded by the RNS® System
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
Group median change in long episode-free day frequency per 28-day period as recorded by the RNS® System
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
Duration, in days, of the longest continuous period of long episode-free days per period as recorded by the RNS® System
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
Duration, in days, between the beginning of the open-label treatment period and the mth long episode, where m is the number of long episodes per 28-day period during the pre-treatment baseline period, as recorded by the RNS® System
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
Group median percent change in estimated electrographic seizure frequency per 28-day period as recorded by the RNS® System
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
Count and proportion of participants with any improvement (minimally improved, much improved, or very much improved) or clinically meaningful improvement (much improved or very much improved) as reported on the Clinical Global Impression of Change (CGI-C) scale
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.
Patient Global Impression of Change [PGI-C] responder count and proportions
Count and proportion of participants with any improvement (minimally improved, much improved, or very much improved) or clinically meaningful improvement (much improved or very much improved) as reported on the Patient Global Impression of Change (PGI-C) scale
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.
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