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ACTIVE NOT RECRUITINGPhase2/Phase3

Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Sponsor: Biohaven Therapeutics Ltd.

NCT ID: NCT06309966

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
BHV-7000 (drug), BHV-7000 (drug), Placebo (drug)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
BHV-7000 — drug: BHV-7000 50 mg. · BHV-7000 — drug: BHV-7000 75 mg. · Placebo — drug: Matching placebo taken once daily
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
390
Started
2024-05-13
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for focal epilepsy
  • • Phase2/Phase3 - 390 participants
  • • The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with focal epilepsy

Where?

  • • Swansea - Morriston Hospital
  • • Glasgow - Queen Elizabeth University Hospital-PPDS
  • • Salford - Salford Royal Hospital - PPDS
  • • Oxford - John Radcliffe Hospital
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Focal Epilepsy

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓Male and Female participants 18 to 75 years of age at time of consent.
  • ✓Ability to keep accurate seizure diaries
  • ✓Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total

Who cannot take part

  • ✗History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior...
  • ✗Resection neurosurgery for seizures \<4 months prior to the screening visit.
  • ✗Radiosurgery performed \<2 years prior to the screening visit.
See the full criteria
Key Inclusion Criteria: 1. Male and Female participants 18 to 75 years of age at time of consent. 2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria. a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures with clinically observable signs and/or symptoms iii. Focal to bilateral tonic-clonic seizures 3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. 4. Ability to keep accurate seizure diaries 5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total Key Exclusion Criteria: 1. History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired consciousness for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure. 2. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase. 3. Resection neurosurgery for seizures \<4 months prior to the screening visit. 4. Radiosurgery performed \<2 years prior to the screening visit. 5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms. 6. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator

Where Is This Study? (9 UK sites)

Morriston Hospital

Swansea SA6 6NL, United Kingdom

Queen Elizabeth University Hospital-PPDS

Glasgow G51 4TF, United Kingdom

Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

Salford Royal Hospital - PPDS

Salford M6 8HD, United Kingdom

John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

University Hospital of Wales

Cardiff CF14 4XW, United Kingdom

Hospital R&D contact (matched)

Elen de Lacy

PHW.Research@wales.nhs.uk02920 104468

King's College Hospital

London SE5 9RS, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

St Georges NHS Foundation Trust

London SW17 0QT, United Kingdom

Hospital R&D contact (matched)

Tania West, R&D Governance & Clinical Trials Manager

tania.west@swlstg.nhs.uk020 3513 6420

The Royal London Hospital

London WC1N 3HR, United Kingdom

Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Royal Victoria Infirmary

Newcastle upon Tyne NE1 4LP, United Kingdom

Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815
Data sourced from ClinicalTrials.gov · Last verified: 2026-08