Health Trials

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

ConditionFocal Epilepsy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBiohaven Therapeutics Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and Female participants 18 to 75 years of age at time of consent.

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.

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.

Ability to keep accurate seizure diaries

Disqualifiers

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.

History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.

Resection neurosurgery for seizures <4 months prior to the screening visit.

Radiosurgery performed <2 years prior to the screening visit.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BHV-7000

    Drug

    BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily

  • BHV-7000

    Drug

    BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily

  • Placebo

    Drug

    Matching placebo taken once daily

  • BHV-7000

    Drug

    BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily

  • Placebo

    Drug

    Matching placebo taken once daily

Treatment groups

390 Participants
are divided into 5 treatment groups
Group A: BHV-7000 25 mg Part AExperimental treatment 1 intervention
Group B: BHV-7000 50 mg Part AExperimental treatment 1 intervention
Group C: Placebo Part APlacebo comparator 1 intervention
Group D: BHV-7000 75 mg Part BExperimental treatment 1 intervention
Group E: Placebo Part BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part B: Change from Baseline in 28-day average seizure frequency

To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.

Time frame
Baseline, Week 8 to Week 20 of Part B
2

Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs

To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.

Time frame
Week 8 to Week 20 of Part A
3

Part A: Number of Participants With Clinically Significant Laboratory Abnormalities

To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.

Time frame
Week 8 to Week 20 of Part A

Secondary outcomes

1

Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month

To compare the efficacy of 2 dose strengths of BHV-7000 to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 12 week double-blind phase to the observation phase.

Time frame
Baseline, Week 8 to Week 20 of Part B
2

Part B: Change from Baseline in 28-day average seizure frequency during first month of treatment

To compare the efficacy of BHV-7000 to placebo during the first month of treatment. This objective will be measured by the change in log-transformed 28-day adjusted seizure frequency from observation phase over the first month of the double blind phase.

Time frame
Baseline, Week 8 to Week 12 of Part B
3

Part B: Percentage of Participants with at at least 75% reduction in seizure frequency per month

To compare the efficacy of BHV-7000 to placebo as measured by the proportion of subjects that have at least a 75% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the double-blind phase compared to the observation phase.

Time frame
Baseline, Week 8 to Week 20 of Part B
4

Part B: Percentage of Participants with seizure freedom during DB Phase

To compare the efficacy of BHV-7000 to placebo on seizure freedom (100% seizure reduction during the DB phase). This objective will be measured by proportion of subjects that are seizure free during the double-blind phase.

Time frame
Week 8 to Week 20 of Part B

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biohaven Therapeutics Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now