Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1

Part of paid clinical trials in Palmdale, California.

Sponsor
Rapport Therapeutics Inc.
Study ID
NCT07563881
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • RAP-219 — DRUG
    RAP-219 high dose tablets administered orally daily
  • RAP-219 — DRUG
    RAP-219 medium dose tablets administered orally daily
  • Placebo — OTHER
    Matching placebo tablets administered orally daily

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Jul 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
333 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Arm- High Dose
    RAP-219 daily tablets administered orally
  • Experimental: Active Arm- Medium Dose
    RAP-219 daily tablets administered orally
  • Placebo Comparator: Placebo
    Inert comparator matching the active treatment

Primary Outcome Measure

Median Percent Change in Seizure Frequency [ Time Frame: End of double-blind treatment period (end of week 14) vs Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Amicis Research CenterPalmdaleCalifornia91324-
Indiana University Health Fort Wayne NeurologyFort WayneIndiana46804-

Find similar trials in Palmdale, CA

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Amicis Research Center· Palmdale, CAIndiana University Health Fort Wayne Neurology· Fort Wayne, IN

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