Epilepsy, Focal Epilepsy, Focal Seizure
Conditions
Keywords
Focal Preserved Consciousness, Focal Impaired Consciousness
Brief summary
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
DRUGRAP-219
RAP-219 medium dose tablets administered orally daily
OTHERPlacebo
Matching placebo tablets administered orally
Sponsors
Rapport Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a placebo-controlled trial of active drug versus placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 - 75 2. BMI 18-45 kg/m2 3. Diagnosis of focal epilepsy for ≥24 months prior to Visit 1 4. 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 5. Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs 6. Ability to keep accurate daily focal seizure records using an e-diary
Exclusion criteria
1. Known hypersensitivity or prior exposure to RAP-219. 2. Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur 3. Anticipated need for surgery during the study period 4. Medical history of any of the following: 1. generalized epilepsy 2. focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type 3. psychogenic nonepileptic seizure (PNES) 4. status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56). 5. epilepsy surgery within 12 months prior to Visit 1 (Day -56). 5. Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Percent Change in Seizure Frequency | End of double-blind treatment period (end of week 14) vs Baseline | Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ≥50% seizure frequency reduction responder rates | End of double-blind treatment period (end of week 14) vs Baseline. | Proportion of participants with at least 50% reduction from baseline in seizure frequency after treatment with RAP-219 compared with placebo |
| Longest Seizure Free Interval | Across the entire 14-week double-blind treatment period | To evaluate the longest seizure-free interval after treatment with RAP-219 compared with placebo |
Countries
United States
Contacts
CONTACTRapport Medical
PRINCIPAL_INVESTIGATORVicente Villaneuva, M.D., PhD
Hospital Universitari i Politecnic La Fe, Spain
Outcome results
None listed