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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 week 8 to week 20
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with Focal Onset Epilepsy over a year ago.
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I experience seizures that start in one area of my brain.
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My epilepsy is drug-resistant according to the 2009 ILAE definition.
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I am currently on 1-3 seizure medications and have tried up to 4 treatments in total.
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You can keep a detailed record of your seizures.
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I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8 to week 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8 to week 20
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in 28-day average seizure frequency
Secondary study objectives
Change from Baseline in 28-day average seizure frequency during first month of treatment
Change from baseline in 7-day adjusted seizure frequency during first week of treatment
Change from baseline in Patient Global Impression of Change (PGI-C)
+5 moreTrial 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
11 Previous Clinical Trials
4,306 Total Patients Enrolled
3 Trials studying Epilepsy
1,292 Patients Enrolled for Epilepsy