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Anti-epileptic Drug

BHV-7000 75 mg 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 baseline, week 8 to week 16

Awards & highlights

RISE 3 Trial 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.Check my eligibility

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.See study design

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.

RISE 3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8 to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8 to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 to week 16 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 16 of Treatment

RISE 3 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

Do I qualify?Apply below to find out

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.

Does this study allow individuals who are at least 18 years old to participate?

"Potential participants must be between the ages of 18 and 75 to meet the study's eligibility criteria. Specifically, there are 105 trials for individuals under 18 years old and 167 studies targeting those over 65."

Answered by AI

Are multiple medical facilities in Canada conducting this research study?

"The current trial is operational at 12 sites, with bases in Miami, Charleston, and Chattanooga among others. Opting for the nearest location can reduce travel requirements for potential participants."

Answered by AI

Do I meet the necessary requirements to participate in this clinical investigation?

"Individuals diagnosed with epilepsy within the age range of 18 to 75 are eligible for participation in this research study, which has a total capacity of 390 participants."

Answered by AI

Are new participants currently being recruited for this ongoing medical study?

"The information on clinicaltrials.gov shows that patient recruitment for this study is closed. The trial was first listed on March 1, 2024, and the most recent update was made on March 8, 2024. Despite this trial no longer accepting participants, there are currently 251 other trials actively seeking patients to enroll in their studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

2024. "Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06309966.

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