← Back to Search

Anti-epileptic Drug

BHV-7000 for Epilepsy (RISE 2 Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Biohaven Therapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 with clinically observable signs and/or symptoms iii. Focal to bilateral tonic-clonic seizures
Must not have
Subjects who are detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8 to week 20
Awards & highlights

RISE 2 Trial Summary

This trial will test if a new drug is effective for treating epilepsy that can't be treated with existing drugs.

Who is the study for?
This trial is for adults aged 18-75 with refractory focal onset epilepsy, who have tried at least two anti-seizure medications without success. Participants should be able to track their seizures and may be on up to three anti-seizure meds plus one additional treatment like a diet regimen or device.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of BHV-7000 compared to a placebo in treating refractory focal epilepsy. Patients will either receive BHV-7000 or an inactive substance (placebo) without knowing which one they are taking.See study design
What are the potential side effects?
While specific side effects of BHV-7000 aren't listed, common side effects for epilepsy treatments can include dizziness, fatigue, gastrointestinal issues, mood changes, skin rashes, and coordination problems.

RISE 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with Focal Onset Epilepsy over a year ago.
Select...
I experience seizures that start in one area of my brain.
Select...
My epilepsy is drug-resistant according to the 2009 ILAE definition.
Select...
I am currently on 1-3 seizure medications and have tried up to 4 treatments in total.
Select...
You can keep a detailed record of your seizures.
Select...
I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

RISE 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8 to week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 to week 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in 28-day average seizure frequency during Weeks 8 to 20 of Treatment

RISE 2 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: BHV-7000 50 mgExperimental Treatment1 Intervention
Group II: BHV-7000 25 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Biohaven Therapeutics Ltd.Lead Sponsor
1 Previous Clinical Trials
390 Total Patients Enrolled
1 Trials studying Epilepsy
390 Patients Enrolled for Epilepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are implementing this experimental protocol?

"This trial is active at WRN in Rogers, University of California San Diego in La Jolla, Profound Research LLC in Pasadena and an additional 31 sites."

Answered by AI

Is this research protocol inclusive of individuals aged 45 and older?

"Based on the clinical trial's requirements, individuals must be between 18 and 75 years old to qualify for enrollment."

Answered by AI

Are researchers still recruiting participants into this clinical trial?

"The information on clinicaltrials.gov shows that this particular trial is no longer seeking participants, as it was initially posted in December 1st 2023 and last edited November 22nd 2023. However, 258 other medical studies are still actively enrolling patients at the moment."

Answered by AI

Am I eligible to participate in this research project?

"This medical experiment seeks 390 individuals with epilepsy, aged 18 to 75. Qualifying participants need to possess the following qualities: Capability of accurately keeping track of their seizures, current treatment using at least 1 and up to 3 anti-seizure medications (ASMs) combined with a maximum total of four treatments (e.g., three ASMs + one dietary regimen; two ASMs + one dietary regimen + one device etc.), diagnosis of Focal Onset Epilepsy that occurred at least 12 months before screening visit as defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy"

Answered by AI

Who else is applying?

What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I've tried 3 other medications that didn't work. I'm still in search for an effective combination of medicines to control my epileptic seizures since 1980 since the young age of six.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long does the trial last?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
2024. "A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132893.
All > Phoenix > Honolulu
~260 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top