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Enrolling by invitationPHASE2INTERVENTIONAL

Long-term Safety and Tolerability of BHV-7000

This research study is investigating a new medicine called BHV-7000, specifically for adults who have a type of epilepsy called focal epilepsy. Focal epilepsy means seizures start in one part of the brain. The study is particularly interested in how safe BHV-7000 is and how well people can tolerate it over a longer period. Participants in this study will have already taken part in an earlier study looking at the same medication. It's designed to gather more information on the drug's long-term effects. The main aim is to find out if BHV-7000 is safe and if people can continue taking it without too many side effects. This kind of research helps doctors understand new treatments better before they can be made widely available.

At a glance

Status
Enrolling by invitation
Phase
PHASE2
Sponsor
Biohaven Therapeutics Ltd.
Enrolment target
660
Start
30 Jul 2024
Estimated completion
01 Jan 2027
Focal Epilepsy

What is this study about?

This study is about a new medication called BHV-7000, which is being investigated for treating focal epilepsy. Focal epilepsy is a common type of epilepsy where seizures begin in a specific area of the brain. The doctors and researchers involved in this study want to understand if BHV-7000 is safe to use for a longer time and if people can tolerate it well without experiencing too many unwanted side effects. This is a very important step in developing new treatments.

You might be interested in this study if you've previously taken part in an earlier study for BHV-7000 (specifically studies BHV7000-302 or BHV7000-303). This follow-up study allows researchers to collect more information about the drug's long-term safety and how it affects people over time. This information is crucial for understanding the potential benefits and any risks associated with the medicine.

Studies like this are vital for developing new medicines. By carefully monitoring participants and collecting data, researchers can learn more about how a new drug works, its safety profile, and if it could eventually become a helpful new treatment option for people living with focal epilepsy. Your participation, if eligible, would contribute significantly to this important medical research.

Key takeaways

  • This study is for people aged 18 to 75 with focal epilepsy.
  • It's about a new medicine, BHV-7000, and its long-term safety.
  • You must have completed earlier BHV-7000 studies to join this one.
  • The study aims to see if BHV-7000 is safe and well-tolerated over time.
  • Your health will be closely monitored by a medical team.

Who may be eligible?

To join this study, you must have already completed the previous study of BHV-7000 (either study BHV7000-302 or BHV7000-303). This is because this study is a continuation to see how the medication affects people over a longer period.

If you are a woman who could become pregnant, you will need to have a negative pregnancy test at the start of the study to make sure you are not pregnant. This is a standard safety measure for many medical studies.

You cannot join this study if you have any health problems or ongoing side effects from the previous study that would make it difficult for you to follow the study instructions, put you at risk, or make it hard for the doctors to properly understand the study results. The study doctor will carefully check your overall health and previous experiences with the medication to ensure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am between 18 and 75 years old.
  2. I have focal epilepsy.
  3. I previously took part in the BHV-7000-302 or BHV-7000-303 study.
  4. I don't have any serious health issues that would make taking part unsafe for me.
  5. If I am a woman who could become pregnant, I am willing to have a pregnancy test.
Answer every question to see your result.

What does participation involve?

If you take part in this study, you will continue to receive the study medication, BHV-7000. You will have regular visits with the study team, who will monitor your health, ask about any side effects you might be experiencing, and perform any necessary tests. This will help them understand how the medication is affecting you over the long term. The exact number of visits, tests, and the total duration of your participation will be explained in detail by the study team before you decide to join.

Potential risks and benefits

Taking part in a study like this means you'd be among the first to receive a new long-term treatment under close medical supervision. While there are potential benefits in contributing to medical knowledge and potentially benefiting from the treatment, there are also potential risks related to side effects of the medication, which will be fully explained. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (283)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Accel Research
    Verified postcode
    Birmingham, United States
  • Onyx Clinical Trials
    Verified postcode
    Peoria, United States
  • Xenoscience, Inc.
    Verified postcode
    Phoenix, United States
  • University of Arizona / Banner University Medical Center Phoenix
    Verified postcode
    Phoenix, United States
  • Barrow Neurological Institute
    Verified postcode
    Phoenix, United States
  • ARENSIA Exploratory Medicine
    Verified postcode
    Phoenix, United States
  • Center for Neurosciences
    Verified postcode
    Tucson, United States
  • Clinical Trials, Inc.
    Verified postcode
    Little Rock, United States
  • WRN
    Verified postcode
    Rogers, United States
  • University of California San Diego
    Verified postcode
    La Jolla, United States
  • Amicis Research Center
    Verified postcode
    Lancaster, United States
  • Memorialcare Miller Children's & Women's Hospital Long Beach
    Verified postcode
    Long Beach, United States

Common questions

What is focal epilepsy?

Focal epilepsy is a type of epilepsy where seizures start in one specific part of the brain, rather than affecting the whole brain at once.

What is BHV-7000?

BHV-7000 is a new medication being tested in clinical trials for treating focal epilepsy. This study is looking at its long-term safety.

Why is this study only for people who were in previous BHV-7000 studies?

This study is a follow-up to gather more information on the long-term safety and tolerability of BHV-7000 for people who have already started taking it in earlier stages of research.

Will I receive new medication?

You will continue to receive BHV-7000 as part of this study, as it builds on your participation in prior BHV-7000 studies.

How long will the study last?

The exact total duration of the study for each person will be explained by the study team, as it focuses on long-term safety after previous study participation.

How to find out more

Official trial record

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

Interested in taking part?

Register your interest

Share your details and the research team for "Long-term Safety and Tolerability of BHV-7000…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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