Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects with Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures, with Open-label Extension

This research study is looking at a new medication called BHV-7000. It's for adults aged 18 and older who have a specific kind of epilepsy where they experience generalised tonic-clonic seizures, often called grand mal seizures. The main goal of the study is to find out if BHV-7000 can help reduce how often these seizures happen and to check if the medicine is safe and well-tolerated. Some participants will receive the new medicine, while others will receive a placebo (a dummy pill) to compare the effects. This will help researchers understand if BHV-7000 is a good treatment option for this type of epilepsy.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Biohaven Therapeutics Ltd.

Enrolment target

122

Start

07 Oct 2024

Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures

What is this study about?

This study is designed to test a new medicine, BHV-7000, for people who experience a specific type of epilepsy. This type is called idiopathic generalised epilepsy with generalised tonic-clonic seizures. These are whole-body seizures that can affect people unexpectedly. The word 'idiopathic' simply means we don't know the exact cause of the epilepsy. Currently, there are treatments available for epilepsy, but researchers are always looking for new and better ways to control seizures and improve the quality of life for those affected. This new medicine aims to help reduce the frequency of these seizures.

The study is split into two main sections: Phase 2 and Phase 3. Phase 2 studies generally look at how well a new medicine works and what dose might be best, while Phase 3 studies look at how effective the new medicine is against a placebo and collect more information on side effects in a larger group of people. In this study, some people will receive the new medicine, while others will receive a placebo, which looks identical but contains no active drug. This allows the researchers to fairly compare the new medicine's effects.

The main thing the researchers want to find out is whether BHV-7000 can help to delay the time until someone has their second tonic-clonic seizure. They will also be carefully monitoring how safe the medicine is and looking at any side effects people might experience. They hope that this study will show BHV-7000 could be a valuable new treatment option for people living with this type of epilepsy.

Key takeaways

This study is testing a new medicine, BHV-7000, for adult epilepsy patients.
It's for people with idiopathic generalised epilepsy and tonic-clonic seizures.
The study aims to see if the medicine reduces seizures and is safe.
Some participants will receive the active medicine, and others a placebo.
You will have careful medical monitoring throughout the study.
You can withdraw from the study at any time if you change your mind.

Who may be eligible?

This study is for adults aged 18 years and older who have a specific type of epilepsy. This particular kind of epilepsy is called idiopathic generalised epilepsy, and it's characterized by having generalised tonic-clonic seizures. Both men and women are eligible to take part.

To be considered for the study, you would need to have received a diagnosis of this specific epilepsy type from a doctor. You would also need to be experiencing these tonic-clonic seizures even with your current treatment. The study team will check your medical history to make sure that the study is a good fit for you and safe for you to participate in.

There might be other detailed health requirements that only the study team can fully explain. For example, certain other health conditions or medications might prevent you from joining. It's always best to discuss your full medical history with the study doctor.

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.

Are you 18 years old or older?
Do you have a diagnosis of idiopathic generalised epilepsy?
Do you experience generalised tonic-clonic seizures?
Are you currently taking medication for your epilepsy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new study medicine, BHV-7000, or a placebo (a dummy pill that looks the same but has no active ingredient). Neither you nor your study doctor will know which one you are receiving during the main part of the study, which is called the 'double-blind phase.' You will need to take the study medication regularly as instructed.

Your participation will involve regular visits to the study clinic. During these visits, doctors and nurses will monitor your health, perform various medical checks, and ask you about your seizures and how you are feeling. This includes physical examinations, blood tests, and perhaps other assessments. The main part of the study will last for a certain period, and then there will be an 'open-label extension.' This means everyone can then receive the active study medicine, and regular follow-up visits will continue to monitor your long-term health and seizure control. The total duration of your involvement could be quite long, extending for several months or even longer, but the study team will explain the exact timeline.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, such as receiving a new investigational medication that might improve your seizure control. You will also receive careful medical monitoring by a specialist team throughout the study. However, there are also potential risks; for example, the new medicine might cause side effects, or it might not work effectively for you. As some participants will receive a placebo, you may not be receiving active treatment during the initial phase. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium
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Unverified
Netherlands
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Unverified
Germany
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Unverified
Austria
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Unverified
Italy
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Unverified
Finland
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Unverified
Poland
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Unverified
France
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Unverified
Portugal
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Unverified
Spain
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Unverified
Croatia

Common questions

What is a placebo?

A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the new medicine fairly.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know whether you are receiving the new medicine or the placebo. This helps prevent bias in the study results.

Will I stop my current epilepsy medication if I join?

The study is designed to test the new medicine as an 'add-on' therapy, meaning it would be taken alongside your current epilepsy medication. Your current treatment would likely continue, but the study team will provide specific guidance.

How long will the study last?

The study has two main parts: a 'double-blind phase' and an 'open-label extension.' Your total involvement could last several months or longer, but the exact duration will be explained by the study team.

What are tonic-clonic seizures?

Tonic-clonic seizures are a type of seizure where a person's body stiffens (tonic phase) and then jerks (clonic phase). They are sometimes called grand mal seizures.