This clinical trial is focused on studying Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures. The trial will evaluate a treatment called BHV-7000, which is a prolonged-release tablet developed by Biohaven Therapeutics Ltd. The purpose of the study is to compare the effectiveness of BHV-7000 to a placebo when used as an additional therapy for people with this type of epilepsy.
Participants in the study will receive either the BHV-7000 tablet or a placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The trial will include an open-label extension, which means that after the initial phase, all participants may have the opportunity to receive BHV-7000 if they choose to continue. The study will last for a period of up to 72 weeks.
The main goal is to observe the time it takes for participants to experience a second day with a generalized tonic-clonic seizure during the double-blind phase. Additionally, the study will assess the safety and tolerability of BHV-7000 by monitoring any side effects or adverse events that occur. This trial aims to provide valuable information on the potential benefits and risks of using BHV-7000 as a treatment option for individuals with this form of epilepsy.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of idiopathic generalized epilepsy with generalized tonic-clonic seizures and ensuring the participant meets the criteria for drug-resistant epilepsy.
2double-blind phase
Participants are randomly assigned to receive either the study medication BHV-7000 or a placebo. Both are administered as prolonged-release tablets taken orally.
The primary goal during this phase is to measure the time to the second day with a generalized tonic-clonic seizure. The duration of this phase is 24 weeks.
3medication administration
Participants take the assigned medication daily. The dosage and specific instructions are provided by the study team and must be followed precisely.
4monitoring and evaluation
Throughout the study, participants are monitored for seizure activity and any side effects. This includes regular visits to the study site for assessments and to ensure safety and tolerability of the treatment.
5open-label extension
After completing the double-blind phase, participants may enter an open-label extension where all receive BHV-7000. This phase allows for continued monitoring of efficacy and safety.
6study completion
The study is estimated to conclude by November 2027. Final evaluations are conducted to assess the overall outcomes and any long-term effects of the treatment.
Who Can Join the Study?
Participants must be male or female and between 18 to 75 years old at the time they agree to join the study.
Participants need to have been diagnosed with Idiopathic Generalized Epilepsy (IGE) for at least 6 months before the screening visit. This diagnosis should follow the guidelines set by the 2017 International League Against Epilepsy (ILAE).
Participants should have generalized tonic-clonic (GTC) seizures as part of their IGE. This means they have GTC seizures and specific patterns on an electroencephalogram (EEG), which is a test that measures brain activity. They should not have any focal abnormalities, which means no unusual activity in a specific part of the brain.
Participants should meet the 2009 ILAE definition of drug-resistant epilepsy. This means they have tried at least two different anti-seizure medications, either alone or together, but these have not successfully stopped their seizures.
Participants or their caregivers must be able to keep accurate seizure diaries, which are records of when seizures happen.
Participants should currently be on treatment with 1 to 3 anti-seizure medications (ASMs), and they can have up to 4 different epilepsy treatments in total. This could include medications, a special diet, or a device.
Participants need to have a history of having at least 3 days with a GTC seizure spread out over the 16 weeks before the screening visit. This means they should have had at least one day with a GTC seizure in the first 8 weeks and at least one day with a GTC seizure in the second 8 weeks.
Who Cannot Join the Study?
Patients who have a different type of epilepsy than Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures. This means if your seizures are not of this specific type, you cannot participate.
Patients who are not within the specified age range for the study. The study has specific age requirements, so if you are too young or too old, you may not be eligible.
Patients who are not able to follow the study procedures or take the study medication as required. This means if you have difficulty understanding or following the study rules, you might not be able to join.
Patients who have other medical conditions that might interfere with the study. If you have other health issues that could affect the study results, you may not be allowed to participate.
Patients who are pregnant or breastfeeding. If you are expecting a baby or nursing, you cannot take part in the study.
Patients who are currently participating in another clinical trial. If you are already involved in a different study, you cannot join this one.
Patients who have a history of drug or alcohol abuse. If you have had problems with substance abuse, you may not be eligible for the study.
Patients who have had a recent change in their epilepsy medication. If your medication has been adjusted recently, you might not be able to participate.
BHV-7000 is a medication being studied as an additional treatment for people with a type of epilepsy called idiopathic generalized epilepsy, which includes generalized tonic-clonic seizures. The trial aims to see how effective and safe BHV-7000 is when used alongside other treatments. The study will measure how long it takes for a person to have a second day with a seizure while taking this medication.
Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures – This is a type of epilepsy characterized by seizures that involve the entire brain from the onset. The seizures, known as generalized tonic-clonic seizures, typically begin with a loss of consciousness and muscle stiffening, followed by rhythmic muscle contractions. These seizures can occur without any identifiable cause, hence the term “idiopathic.” The condition often starts in childhood or adolescence and can continue into adulthood. The frequency and severity of the seizures can vary widely among individuals. Over time, the pattern of seizures may change, but the condition generally persists throughout life.
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