Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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
Qualifiers
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
Treatments tested in this trial
- RAP-219
- RAP-219
- Placebo
Treatment groups
333 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov