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Anti-epileptic Drug

BHV-7000 for Epilepsy (RISE 3 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8 to week 16

Summary

This trial aims to find out if BHV-7000 is helpful in treating focal epilepsy that has not responded well to other treatments.

Who is the study for?
This trial is for adults with refractory focal onset epilepsy, which means their seizures aren't well-controlled by current medications. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.
What is being tested?
The study is testing the effectiveness and safety of a medication called BHV-7000 in treating refractory focal epilepsy. Participants will either receive BHV-7000 or a placebo to compare outcomes between the two groups.
What are the potential side effects?
While specific side effects of BHV-7000 are not listed, common side effects for epilepsy medications can include dizziness, fatigue, nausea, and potential mood changes. The exact side effects will vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8 to week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 to week 16 for reporting.

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 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: BHV-7000 75 mgExperimental Treatment1 Intervention
Group II: BHV-7000 50 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
4,246 Total Patients Enrolled
3 Trials studying Epilepsy
1,292 Patients Enrolled for Epilepsy
~251 spots leftby Aug 2025
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