In short
There is currently 1 ongoing clinical trial for idiopathic generalised epilepsy, evaluating a new medication called BHV-7000 as an additional treatment option for people experiencing generalized tonic-clonic seizures. The trial is being conducted across multiple European countries and aims to assess both the effectiveness and safety of this investigational drug when used alongside existing epilepsy treatments.
Clinical trial locations
- Austria
- Belgium
- Croatia
- Finland
- France
- Germany
- Italy
- Netherlands
- Poland
- Portugal
- Spain
Study on BHV-7000 for Patients with Generalized Tonic-clonic Seizures in Idiopathic Generalized Epilepsy
This clinical trial is investigating a new treatment option for people with idiopathic generalised epilepsy who experience generalized tonic-clonic seizures. The study is testing BHV-7000, a prolonged-release tablet that will be used alongside existing epilepsy medications to see if it can help reduce seizure frequency.
Who can participate:
To be eligible for this study, participants must be adults between 18 and 75 years old who have been diagnosed with idiopathic generalised epilepsy for at least 6 months. The diagnosis should follow the 2017 International League Against Epilepsy guidelines. Participants need to have generalized tonic-clonic seizures with specific patterns on an electroencephalogram test, but without any focal brain abnormalities.
An important requirement is that participants must have drug-resistant epilepsy, meaning they have tried at least two different anti-seizure medications without successfully controlling their seizures. Participants should currently be taking 1 to 3 anti-seizure medications and may have up to 4 different epilepsy treatments in total, which could include medications, a special diet, or a device.
Participants must have experienced at least 3 days with a generalized tonic-clonic seizure during the 16 weeks before joining the study, with at least one seizure day in each 8-week period. They or their caregivers must also be able to keep accurate records of when seizures occur.
Who cannot participate:
The study excludes people who have a different type of epilepsy other than idiopathic generalised epilepsy with generalized tonic-clonic seizures. Those who fall outside the specified age range or who cannot follow the study procedures or take the medication as required are also not eligible.
Other exclusion criteria include having medical conditions that might interfere with the study, being pregnant or breastfeeding, currently participating in another clinical trial, having a history of drug or alcohol abuse, or having recently changed epilepsy medication.
What the trial involves:
The trial will last up to 72 weeks and is designed as a double-blind study, which means neither participants nor researchers will know who is receiving BHV-7000 and who is receiving a placebo. The main goal is to measure the time it takes for participants to experience a second day with a generalized tonic-clonic seizure during a 24-week double-blind phase.
Participants will take their assigned medication daily and will have regular visits to monitor seizure activity and any side effects. After completing the double-blind phase, all participants may have the opportunity to continue receiving BHV-7000 in an open-label extension phase, where everyone knows they are receiving the actual medication. This allows for continued monitoring of both effectiveness and safety.
About BHV-7000:
BHV-7000 is an antiepileptic drug currently in Phase 2/3 clinical trials. It works at the molecular level by modulating specific neurotransmitter pathways in the brain to help stabilize neuronal activity. The medication is taken orally as a prolonged-release tablet and is being studied specifically for its ability to reduce the frequency of generalized tonic-clonic seizures when used as an additional therapy alongside existing treatments.
Summary
Currently, there is one active clinical trial for idiopathic generalised epilepsy, specifically targeting patients with generalized tonic-clonic seizures who have not achieved adequate seizure control with existing medications. The trial is notably widespread across Europe, being conducted in 11 countries including Germany, Italy, Croatia, Spain, Poland, Austria, Portugal, Netherlands, Belgium, France, and Finland.
The study focuses exclusively on BHV-7000, an investigational antiepileptic medication developed by Biohaven Therapeutics Ltd. This represents an important research effort for people with drug-resistant epilepsy, as the trial specifically targets those who have tried multiple medications without success. The study is expected to conclude by November 2027 and will provide valuable information about both the effectiveness and safety of this new treatment approach.
