NCT06132893 · Biohaven Therapeutics Ltd.
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
(RISE 2)
What this study is about
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
View original scientific description
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Interventions
DRUG
BHV-7000
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
DRUG
BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
DRUG
Placebo
Matching placebo taken once daily
DRUG
BHV-7000
BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
DRUG
Placebo
Matching placebo taken once daily
Primary outcome measures
Part B: Change from Baseline in 28-day average seizure frequency
Time frame: Baseline, Week 8 to Week 20 of Part B
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.
Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time frame: Week 8 to Week 20 of Part A
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
Part A: Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Week 8 to Week 20 of Part A
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and Female participants 18 to 75 years of age at time of consent. 2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria. a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures 3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. 4. Ability to keep accurate seizure diaries 5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total Key
Exclusion criteria
- History of status epilepticus (convulsive status epilepticus for \> 5 minu
Where
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Rogers, Arkansas
- La Jolla, California
- Los Angeles, California
- Palo Alto, California
- Pasadena, California
- Aurora, Colorado
- New Haven, Connecticut
- Boca Raton, Florida
- Bradenton, Florida
And 45 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations