Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRapport Therapeutics Inc.
About this trial
This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 - 75
BMI 18-45 kg/m2
Diagnosis of focal epilepsy for ≥24 months prior to Visit 1
Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis
Disqualifiers
Known hypersensitivity or prior exposure to RAP-219.
Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur
Anticipated need for surgery during the study period
generalized epilepsy
Trial design
Design model
Parallel
Treatments tested in this trial
RAP-219
DrugRAP-219 medium dose tablets administered orally daily
RAP-219
DrugRAP-219 low dose tablets administered orally daily
Placebo
Other interventionMatching placebo tablets administered orally
Treatment groups
312 Participants
are divided into 3 treatment groupsGroup A: Active Arm- Medium DoseExperimental treatment 1 intervention
Group B: Active Arm-Low DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Median Percent Change in Seizure Frequency
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates
Time frame
End of double-blind treatment period (end of week 14) vs BaselineSecondary outcomes
1
≥50% seizure frequency reduction responder rates
Proportion of participants with at least 50% reduction from baseline in seizure frequency after treatment with RAP-219 compared with placebo
Time frame
End of double-blind treatment period (end of week 14) vs Baseline.2
Longest Seizure Free Interval
To evaluate the longest seizure-free interval after treatment with RAP-219 compared with placebo
Time frame
Across the entire 14-week double-blind treatment periodOther outcomes
1
Incidence of Adverse Events
incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and AEs leading to discontinuation
Time frame
From Visit 1 through End of Study, on average Week 22.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov