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Recruiting NCT07594119

Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures

Phase III Interventional Focal Seizure Epilepsy Focal Epilepsy

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, RAP-219, Placebo.
Who it may be relevant to
Registry conditions: Focal Seizure, Epilepsy, Focal Epilepsy. Basic parameters: 18 years — 75 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 →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures

Overview

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.

Detailed description

Approximately 312 subjects will be randomized into one of two active treatment groups or placebo in a 1:1:1 randomization ratio (Medium Dosage, Low Dosage and Placebo). After completing the Double-blind Treatment Period, participants will either transition into the RAP-219-FOS-901 long-term safety (open-label extension) study or enter the 8-week post-treatment Follow-up Period of this study.

Interventions

  • Drug RAP-219
    RAP-219 medium dose tablets administered orally daily
  • Drug RAP-219
    RAP-219 low dose tablets administered orally daily
  • Other Placebo
    Matching placebo tablets administered orally

Primary outcome measures

  • Median Percent Change in Seizure Frequency [Time frame: End of double-blind treatment period (end of week 14) vs Baseline]
Secondary outcome measures (2)
  • ≥50% seizure frequency reduction responder rates [Time frame: End of double-blind treatment period (end of week 14) vs Baseline.]
  • Longest Seizure Free Interval [Time frame: Across the entire 14-week double-blind treatment period]

Eligibility criteria

Inclusion criteria

  • 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
  • Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs
  • Ability to keep accurate daily focal seizure records using an e-diary

Exclusion criteria

  • 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
  • Medical history of any of the following:
  • generalized epilepsy
  • focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type
  • psychogenic nonepileptic seizure (PNES)
  • status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56).
  • epilepsy surgery within 12 months prior to Visit 1 (Day -56).
  • Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Pillar Clinical Research — Bentonville
  • Colorado Springs Neurological Associates — Colorado Springs
  • K2 Medical Research — Maitland
  • Serenity Research Center, LLC — Miami
  • Velocity Clinical Research — Raleigh
  • University of Texas Health Science Center in Houston — Houston

Identifiers

NCT: NCT07594119 · RAP-219-FOS-302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗