Study on the Effectiveness and Safety of BHV-7000 for Adults with Refractory Focal Onset Epilepsy

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What is this study about?

This clinical trial is focused on studying a condition known as Refractory Focal Onset Epilepsy. This type of epilepsy is characterized by seizures that start in one area of the brain and are resistant to treatment with standard medications. The trial will evaluate a new treatment called BHV-7000, which is a prolonged-release tablet designed to be taken orally. The study will compare two different doses of BHV-7000 to a placebo to determine its effectiveness and safety in reducing the frequency of seizures in adults with this condition.

The purpose of the study is to see if BHV-7000 can help reduce the number of seizures experienced by participants. Participants will be randomly assigned to receive either one of the two doses of BHV-7000 or a placebo. The study will last for about 12 weeks, during which participants will take the medication daily and keep a record of their seizures. The goal is to find out if at least half of the participants experience a significant reduction in their seizure frequency.

Throughout the study, the safety and tolerability of BHV-7000 will be closely monitored. Participants will have regular check-ups to assess their health and any side effects they may experience. The study aims to provide valuable information on whether BHV-7000 can be a beneficial treatment option for those with Refractory Focal Onset Epilepsy.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the medication BHV-7000 or a placebo. The assignment is double-blind, meaning neither the participant nor the researchers will know which one is being administered.

The medication is provided in the form of a prolonged-release tablet, which is taken orally.

2 treatment phase

During the treatment phase, the participant will take the assigned tablet daily. The study aims to compare two different dose strengths of BHV-7000 with a placebo.

The primary goal is to observe if there is at least a 50% reduction in the average number of seizures over a 28-day period.

3 monitoring and assessment

Throughout the study, the participant’s seizure frequency will be monitored using an electronic diary (eDiary). It is important to maintain accurate records, with no more than four missed entries over a 28-day period.

The study will also assess safety by monitoring any adverse effects or changes in health status.

4 completion of the study

The study is expected to conclude by August 18, 2025. At the end of the study, the data collected will be analyzed to determine the effectiveness and safety of BHV-7000 in reducing seizure frequency.

Participants will be informed of the study results and any potential next steps regarding their treatment.

Who Can Join the Study?

  • Must provide a signed written informed consent, which means you agree to participate after understanding the study details.
  • You or your caregiver must be able to read and understand an electronic diary in a language that is available.
  • Must be able to swallow the BHV-7000 tablet whole.
  • Both males and females aged between 18 to 75 years can participate.
  • Must be able to keep accurate records of seizures and miss no more than 4 entries out of 28 days, showing at least 85% compliance with the electronic diary.
  • Must have been diagnosed with Focal Onset Epilepsy at least 1 year before the screening visit. This type of epilepsy starts in one area of the brain.
  • Must experience focal seizures, which can include:
    • Focal aware seizures with noticeable signs or symptoms.
    • Focal impaired awareness seizures with noticeable signs or symptoms.
    • Focal to bilateral tonic-clonic seizures, which start in one area and spread to both sides of the brain.
  • Must have Drug Resistant Focal Onset Seizures, meaning previous treatments did not stop the seizures. This is based on the 2009 definition by the International League Against Epilepsy (ILAE).
  • Currently using no more than 4 epilepsy treatments, with no more than 3 being anti-seizure medications (ASMs). Other treatments can include diet regimens or devices.

Who Cannot Join the Study?

  • Patients who do not have refractory focal onset epilepsy. This means the type of epilepsy that does not respond well to treatment and starts in one area of the brain.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are not considered part of a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Neurosphera Sp. z o.o. Warsaw Poland
Instytut Psychiatrii I Neurologii Warsaw Poland
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Pratia Wroclaw Sp. z o.o. Wroclaw Poland
Chkpocuey Utvldxvajjfijm Sahbarbzb Woluwe-Saint-Lambert Belgium
Nku Lit Gfkwtloqhg Rbradb Mflus Gezg St. Poelten Austria
Upwokobwvq Ow Dlsrctou Debrecen Hungary
Flulttbf nhqtgtpsa Mauoi a Hyhkjah Prague Czechia
Cnhfop Huvrmwjhhch Rrnimwkl Usrpvmorigmpb Db Turba Tours France
Comxjq Hoozjpucxxg Uhhgpgavipxbb Dy Mdccnyekxen Montpellier France
Jjrwtpve Kpjype Upqdfmviau Linz Austria
Covw Di Ngzim Vandoeuvre Les Nancy France
Ctrsaf Hplqyvtmzfa Ucgkxmiwllyhv Dj Rkacei Rennes France
Ugqjgrvavl Oq Ajwkryp Edegem Belgium
Uymcgezexhvy Zyzgnsjgrl Gtfe Gent Belgium
Ccdity Hidaamayvso Lhyy Sui Pierre Benite France
Cpulll Hdhethotlot Uxbzrxmoietji Dnjyfh Gkksnln Smcgaelciypuuhbeohdqvkmrux Namur Belgium
Slchc Swo z ower Lodz Poland
Cbsmkfc Bbuwg Ksmhlbezxck Prcibpwy Sqo z otlg Gdansk Poland
Hrykpgzy Uevmklprihtace Sjkkbtjcfp &chdgnr Hlurkqc dy Hykqarzetss STRASBOURG, Alsace France
Uddtanrzlqb Scjfkphj Salzburg Austria
Ntqvmolv Zbuykiscc I Wrkfvxwyb Sej jq Katowice Poland
Korhuioy blmvztk Stzln Dvk (jevrmnqb Hpnqtuyi „rkxkk Dauom Zagreb Croatia
Kngknqwg bzftnnzn coelnz Rblrbh (tzyjsxmh Hjczajsx Cucuwr Rnqeozg Rijeka Croatia
Brvjhicldcotkihls Kcugwl Ea Rjjqtuwfwnzjgz Budapest Hungary
Clecdg Hvnnlffymgn Uenkddzzzipok Dl Dvbgg Dijon France
Ffsjtott Nunfqcsmi U Sj Awmr V Bhtl Brno-Stred Czechia
Paamjt Sdfl Skorzewo Poland
Ufznyytdqi Oi Pokq Pecs Hungary
Evxxovviq Idgwvuagdput Nfidyamdt Svynlwhgh Zwolle The Netherlands
Myr Ccirmfxy Rirojvdh Pahwbvl Bf Ppfxta Warsaw Poland
Uadutodrrzzph Kthfhrsw Cjxtsh Mcctpnf Maribor Slovenia
Cloapric Bday Sikivjjay Sfj z ocpx Sahi Lublin Poland
Tvjqw Pzcdurfjenc Noakofakeyq Crzksdr Mdbsyvio Sge z oxlh Nowa Sol Poland
Khmtfumjcsfx Heeze The Netherlands
Vajlbomv &bmlx Vbntbgq Suo z oixd Wroclaw Poland
Clclpxmi Htgdqjzl Dqbrmte Zagreb Croatia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
18.07.2024
Belgium Belgium
Not yet recruiting
18.07.2024
Croatia Croatia
Not recruiting
18.07.2024
Czechia Czechia
Not yet recruiting
18.07.2024
France France
Not yet recruiting
18.07.2024
Hungary Hungary
Not yet recruiting
18.07.2024
Poland Poland
Not yet recruiting
18.07.2024
Slovenia Slovenia
Not yet recruiting
18.07.2024
The Netherlands The Netherlands
Not yet recruiting
18.07.2024

Trial locations

Investigated Drugs:

BHV-7000 is a medication being studied for its effectiveness in treating refractory focal onset epilepsy. This type of epilepsy is characterized by seizures that begin in one area of the brain and are resistant to standard treatments. The trial aims to determine if BHV-7000 can help reduce the frequency of seizures when used alongside other epilepsy medications.

Refractory Focal Onset Epilepsy – This is a type of epilepsy where seizures originate in a specific area of the brain and are resistant to standard treatments. Individuals with this condition experience focal seizures, which can affect motor, sensory, or autonomic functions, depending on the brain region involved. These seizures may or may not impair consciousness and can vary in duration and intensity. Over time, the frequency and severity of seizures can fluctuate, making management challenging. The condition is characterized by its persistence despite the use of multiple anti-seizure medications. It requires ongoing monitoring to assess changes in seizure patterns and potential impacts on daily life.

Trial ID:
2023-508539-30-00
Protocol code:
BHV7000-302
NCT ID:
NCT06132893
Trial Phase:
Therapeutic exploratory (Phase II)

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