RecruitingPHASE2, PHASE3INTERVENTIONAL

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

This research study is looking into a new medication, BHV-7000, for adults who have focal epilepsy that hasn't been controlled by their current treatments. Focal epilepsy means seizures start in a specific part of the brain. The study aims to discover if BHV-7000 can effectively reduce seizure frequency and if it is safe to use. Some participants will receive BHV-7000, while others will receive a placebo (a dummy pill with no active medicine) to compare results. This type of research helps doctors understand if new medicines are better than existing options and if they can significantly improve the lives of people living with persistent seizures.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Biohaven Therapeutics Ltd.

Enrolment target

390

Start

13 May 2024

Estimated completion

01 May 2026

Focal Epilepsy

What is this study about?

This study is focused on a specific type of epilepsy called focal epilepsy. This is when seizures begin in one particular area of the brain. For some people, standard medications don't fully control their seizures, which can be very challenging. This study is for adults who are still experiencing seizures despite trying at least two different epilepsy medications.

The main goal is to test a new medicine named BHV-7000. Researchers want to see if this new treatment is safe and if it can help to reduce how often people have focal seizures. By comparing BHV-7000 to a placebo (a pill that looks the same but contains no active medicine), doctors can accurately determine if any improvements are due to the new drug itself.

Taking part in studies like this is really important because it helps scientists find new and better ways to treat conditions like focal epilepsy. It allows us to gather clear information on whether new medications work and if they are safe for people to use, potentially offering hope to those who haven't found effective relief with current treatments.

Key takeaways

This study is for adults (18-75) with focal epilepsy that hasn't responded to other medicines.
It tests a new drug called BHV-7000 to see if it's safe and reduces seizures.
Participation involves taking either BHV-7000 or a placebo and keeping a seizure diary.
You'll have regular medical checks and follow-up appointments.
The study aims to find new and better treatments for hard-to-treat epilepsy.
You can leave the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old. You must have been diagnosed with focal epilepsy for at least a year, and your seizures should still be happening despite trying at least two different epilepsy medications.

You also need to be able to keep a good record of your seizures in a diary. At the moment, you should be taking between one and three epilepsy medications, with a maximum of four different treatments for your epilepsy overall.

There are some reasons you can't join. For example, if you've had certain types of severe or clustered seizures (status epilepticus or repetitive seizures) in the last six months, or if you've had brain surgery for seizures very recently. Also, if your seizures are only very mild, like a brief feeling without losing awareness or having physical symptoms, you might not be eligible. If there's any other medical condition that could make the study unsafe for you or make it difficult to follow the study instructions, you wouldn't be able to participate.

Quick self-check

Are you between 18 and 75 years old?
Have you been diagnosed with focal epilepsy for at least a year?
Do you still have seizures even though you've tried at least two different epilepsy medications?
Are you currently taking 1 to 3 epilepsy medications (and no more than 4 total epilepsy treatments)?
Can you accurately keep a daily record of your seizures?
Have you avoided certain severe or clustered seizures in the last 6 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be given either the new medicine BHV-7000 or a placebo (a dummy pill). Neither you nor your doctor will know which one you are receiving during the main part of the study. You will need to take the medication as instructed and keep accurate daily records of any seizures you experience in a diary.

The study will involve several visits to the clinic for check-ups, where doctors will monitor your health, discuss any side effects, and assess how well the treatment is working. This will include physical exams, blood tests, and possibly other tests to keep track of your condition and safety. There will also be follow-up calls or visits after you finish taking the study medicine.

The total length of your involvement in the study will vary, but it typically involves an initial period of assessment, followed by taking the study medication for a set amount of time, and then a final follow-up period. You will always be informed about the full duration and all required appointments before you agree to participate.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment option if BHV-7000 proves to be effective in reducing your seizures. You would also receive regular medical attention and monitoring from a specialist team. However, as with any new medication, there's a possibility of experiencing side effects, which the study team will carefully monitor. You might also receive the placebo, meaning you wouldn’t get any active medication benefits during that phase. It is important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (174)

Accel Research
Birmingham, United States· Withdrawn
Onyx Clinical Trials
Peoria, United States· Recruiting
Xenoscience, Inc.
Phoenix, United States· Recruiting
University of Arizona / Banner University Medical Center Phoenix
Phoenix, United States· Recruiting
ARENSIA Exploratory Medicine
Phoenix, United States· Recruiting
Clinical Trials, Inc.
Little Rock, United States· Recruiting
Amicis Research Center
Lancaster, United States· Withdrawn
Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, United States· Withdrawn
Tri Valley Neurology Medical Associates, Inc.
Mission Hills, United States· Recruiting
Stanford University
Palo Alto, United States· Withdrawn
Profound Research LLC
Poway, United States· Recruiting
Kaiser Permanente
Aurora, United States· Withdrawn

+162 more sites — see the official record for the full list.

Common questions

What is focal epilepsy?

Focal epilepsy is when seizures start in only one part of the brain. The symptoms can vary depending on which part of the brain is affected.

What does 'refractory' mean in this study?

It means your epilepsy hasn't responded well to standard treatments, and you're still having seizures even after trying at least two different epilepsy medicines.

Why will some people get a 'placebo'?

Giving some people a dummy pill helps researchers compare it to the new medicine. This way, they can be sure any changes in seizure frequency are truly because of the new drug and not other factors.

Will I know if I'm taking the real medicine or the placebo?

During the main part of the study, you and your doctors won't know if you're taking BHV-7000 or the placebo. This helps to keep the study fair and scientific.

What is a 'seizure diary'?

A seizure diary is a record you keep to note down when your seizures happen, what they were like, and how you felt. It's an important way for doctors to track your progress.

How to find out more

Chief Medical Officer

clinicaltrials@biohavenpharma.com 203-404-0410 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.