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

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.
Brief Title
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Detailed Description
Approximately 333 subjects will be randomized into one of two active treatment groups or placebo in a 1:1:1 randomization ratio (High Dosage, Medium 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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
857 323 9048
Central Contact Email
RAP-219-FOS@rapportrx.com
Completion Date
Completion Date Type
Estimated
Conditions
FOCAL SEIZURE
EPILEPSY
FOCAL EPILEPSY
Eligibility Criteria
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
Inclusion Criteria
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

Gender
All
Gender Based
false
Keywords
Focal Preserved Consciousness
Focal Impaired Consciousness
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT07563881
Org Class
Industry
Org Full Name
Rapport Therapeutics Inc.
Org Study Id
RAP-219-FOS-301
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates:
Outcome Measure
Median Percent Change in Seizure Frequency
Outcome Time Frame
End of double-blind treatment period (end of week 14) vs Baseline
Secondary Outcomes
Outcome Description
Proportion of participants with at least 50% reduction from baseline in seizure frequency after treatment with RAP-219 compared with placebo
Outcome Time Frame
End of double-blind treatment period (end of week 14) vs Baseline.
Outcome Measure
≥50% seizure frequency reduction responder rates
Outcome Description
To evaluate the longest seizure-free interval after treatment with RAP-219 compared with placebo
Outcome Time Frame
Across the entire 14-week double-blind treatment period
Outcome Measure
Longest Seizure Free Interval
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Puja Patel
Investigator Email
pupatel@montefiore.org
Investigator Department
Neurology
Investigator Division
Child Neurology
Investigator Sponsor Organization
Montefiore
Study Department
Neurology
Study Division
Pediatric Neurology
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
MeSH Terms
SEIZURES
EPILEPSY
EPILEPSIES, PARTIAL
NEUROLOGIC MANIFESTATIONS
NERVOUS SYSTEM DISEASES
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES