A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy (RISE 2)

April 30, 2026 updated by: Biohaven Therapeutics Ltd.

A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
390

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Recruiting
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1039AAO
        • Recruiting
        • Sanatorio de la Trinidad - Mitre
      • Buenos Aires, Argentina, C1428AQK
        • Recruiting
        • Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI
      • Córdoba, Argentina, X5004AOA
        • Recruiting
        • Instituto Privado Kremer
      • Córdoba, Argentina, X5008HHW
        • Recruiting
        • Conci Carpinella - Santa Rosa N° 748
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1013AAB
        • Recruiting
        • Stat Research S.A.
    • Ciudad Autónoma de BuenosAires
      • Balvanera, Ciudad Autónoma de BuenosAires, Argentina, C1221ADC
        • Recruiting
        • Hospital General de Agudos Dr. José María Ramos Mejia
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1431FWO
        • Recruiting
        • Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1437JCH
        • Recruiting
        • Hospital Británico de Buenos Aires
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Recruiting
        • Investigaciones Sanatorio Del Sur
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Christian Doppler-Klinik - Universitätsklinikum der PMU
      • Sankt Pölten, Austria, 3100
        • Recruiting
        • Universitätsklinikum St. Pölten
      • Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien (Medical University of Vienna)
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Recruiting
        • Kepler Universitätsklinikum Linz - Med Campus III
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • UZ Antwerpen
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Recruiting
        • Hôpital Erasme
      • Brussels, Brussels Capital, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Recruiting
        • CHU UCL Namur - Site Godinne
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4780000
        • Recruiting
        • Centro de especialidades médicas Vanguardia
    • Región-MetropolitanadeSantiago
      • Santiago, Región-MetropolitanadeSantiago, Chile, 8320000
        • Recruiting
        • BIOCINETIC Ltda
      • Santiago, Región-MetropolitanadeSantiago, Chile, 8260094
        • Recruiting
        • Hospital Padre Hurtado
      • Santiago, Región-MetropolitanadeSantiago, Chile, 8320000
        • Recruiting
        • Centro de investigación Clinica UC
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520021
        • Recruiting
        • Instituto Neurologico Thalamus
  • Croatia
      • Rijeka, Croatia, 51000
        • Recruiting
        • Clinical Hospital Center Rijeka - PPDS
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Recruiting
        • Clinical Hospital Sveti Duh
      • Zagreb, City of Zagreb, Croatia, 10000
        • Recruiting
        • Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
  • Czechia
    • Praha, Hlavní Mesto
      • Prague, Praha, Hlavní Mesto, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole
    • South Moravian
      • Brno, South Moravian, Czechia, 602 00
        • Recruiting
        • Fakultni Nemocnice u sv. Anny v Brne
  • France
      • Rennes, France, 35033
        • Recruiting
        • Hôpital Pontchaillou
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67000
        • Not yet recruiting
        • CHU de Strasbourg - Hôpital de Hautepierre
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21000
        • Recruiting
        • CHU Dijon Bourgogne
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
    • Hérault
      • Montpellier, Hérault, France, 34295
        • Recruiting
        • CHU de Montpellier- Hôpital Gui De Chauliac
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37000
        • Recruiting
        • CHRU de TOURS - Hôpital Bretonneau
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54000
        • Recruiting
        • CHRU Nancy
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • CHU de Lille - Hopital Claude Huriez
    • Rhône
      • Lyon, Rhône, France, 69003
        • Recruiting
        • Hospices Civils de Lyon - 59 Bd Pinel
  • Hungary
      • Budapest, Hungary, 1106
        • Recruiting
        • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
      • Budapest, Hungary, 1145
        • Not yet recruiting
        • SE INK Juhasz Pal Epilepszia Központ
    • Baranya
      • Pécs, Baranya, Hungary, 7623
        • Recruiting
        • Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4031
        • Recruiting
        • Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus
  • Netherlands
    • North Brabant
      • Heeze, North Brabant, Netherlands, 5591 VE
        • Recruiting
        • Kempenhaeghe - PPDS
    • North Holland
      • Heemstede, North Holland, Netherlands, 2103 SW
        • Recruiting
        • Stichting Epilepsie Instellingen Nederland - Heemstede
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 BV
        • Recruiting
        • Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
  • Poland
      • Gdansk, Poland, 80-803
        • Recruiting
        • Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
      • Katowice, Poland, 40-594
        • Recruiting
        • Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
      • Krakow, Poland, 30-727
        • Recruiting
        • Pratia Mcm Krakow
      • Krakow, Poland, 31-156
        • Recruiting
        • Landa Specjalistyczne Gabinety Lekarskie
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-702
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-149
        • Recruiting
        • Przychodnia Vistamed
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-078
        • Recruiting
        • Clinical Best Solutions - Lublin
      • Świdnik, Lublin Voivodeship, Poland, 21-040
        • Recruiting
        • NZOZ IGNIS dr med. Alicja Lobinska
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
    • Lódzkie
      • Lodz, Lódzkie, Poland, 90-302
        • Recruiting
        • Santa Familia PTG Lodz
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-172
        • Recruiting
        • MTZ Clinical Research Powered by PRATIA - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 02-829
        • Recruiting
        • Neurosphera SP. Z O.O
      • Warsaw, Masovian Voivodeship, Poland, 02-957
        • Recruiting
        • Instytut Psychiatrii i Neurologii
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Recruiting
        • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Slovenia
      • Maribor, Slovenia, 2000
        • Recruiting
        • University Clinical Centre Maribor
  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7530
        • Recruiting
        • InnoMed Clinical Trial Centre
      • Cape Town, Western Cape, South Africa, 7700
        • Recruiting
        • Groote Schuur Hospital
  • Switzerland
    • Zürich (de)
      • Zurich, Zürich (de), Switzerland, 8008
        • Recruiting
        • Klinik Lengg AG
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
      • Tucson, Arizona, United States, 85718
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
      • Rogers, Arkansas, United States, 72758
        • Withdrawn
        • WRN
    • California
      • La Jolla, California, United States, 92041
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Health Care
        • Contact:
      • Pasadena, California, United States, 91105
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale School of Medicine - Yale-New Haven Hospital
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Bradenton, Florida, United States, 34209
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida (Jacksonville)
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
      • Miami, Florida, United States, 33179
        • Withdrawn
        • Floridian Research Institute
      • Orlando, Florida, United States, 32804
        • Withdrawn
        • AdventHealth Orlando
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Medsol Clinical Research Center
        • Contact:
      • Tampa, Florida, United States, 33615
      • Weston, Florida, United States, 33331
      • Winter Park, Florida, United States, 32789
        • Withdrawn
        • Pediatrix Medical Group of Florida
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
    • Idaho
      • Boise, Idaho, United States, 83702
        • Recruiting
        • Consultants in Epilepsy & Neurology, PLLC
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Revive Research Institute, Inc.
        • Contact:
    • Iowa
      • Ames, Iowa, United States, 50010
        • Withdrawn
        • Accellacare
    • Kentucky
      • Lexington, Kentucky, United States, 40504
    • Maryland
      • Bethesda, Maryland, United States, 20817
      • Silver Spring, Maryland, United States, 20901
        • Completed
        • Javara
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Withdrawn
        • Revive Research Institute, Inc.
    • Minnesota
      • Roseville, Minnesota, United States, 55113
        • Recruiting
        • Minnesota Epilepsy Group, P.A.
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Inst of Neurology
        • Contact:
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurosciences Research Center
        • Contact:
      • Hawthorne, New York, United States, 10532
        • Recruiting
        • BCHP
        • Contact:
      • New York, New York, United States, 10029
        • Withdrawn
        • Icahn School of Medicine at Mt. Sinai
      • New York, New York, United States, 10021
      • Stony Brook, New York, United States, 11794
      • Woodmere, New York, United States, 11598
        • Recruiting
        • Five Towns Neuroscience Research
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Withdrawn
        • OnSite Clinical Solutions
      • Mooresville, North Carolina, United States, 28117
        • Withdrawn
        • Accellacare
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44718
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Contact:
      • Columbus, Ohio, United States, 43214
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
    • Texas
      • Cypress, Texas, United States, 77433
        • Withdrawn
        • Clinical Research Solutions LLC
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Neurology Consultants of Dallas, PA
        • Contact:
      • Fort Worth, Texas, United States, 76104
        • Not yet recruiting
        • Tarrant Neurology Consultants
        • Contact:
      • Houston, Texas, United States, 77030
        • Withdrawn
        • Michael E. DeBakey VA Medical Center
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Ut Health San Antonio
        • Contact:
      • San Antonio, Texas, United States, 78249
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Withdrawn
        • UVM MC
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Contact:
      • Richmond, Virginia, United States, 23235
      • Roanoke, Virginia, United States, 24011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BHV-7000 25 mg Part A
Drug: BHV-7000
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
Drug: BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
Drug: BHV-7000
BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Experimental: BHV-7000 50 mg Part A
Drug: BHV-7000
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
Drug: BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
Drug: BHV-7000
BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Placebo Comparator: Placebo Part A
Drug: Placebo
Matching placebo taken once daily
Experimental: BHV-7000 75 mg Part B
Drug: BHV-7000
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
Drug: BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
Drug: BHV-7000
BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Placebo Comparator: Placebo Part B
Drug: Placebo
Matching placebo taken once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part B: Change from Baseline in 28-day average seizure frequency
Time Frame: Baseline, Week 8 to Week 20 of Part B
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.
Baseline, Week 8 to Week 20 of Part B
Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time Frame: Week 8 to Week 20 of Part A
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.
Week 8 to Week 20 of Part A
Part A: Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Week 8 to Week 20 of Part A
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.
Week 8 to Week 20 of Part A

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month
Time Frame: Baseline, Week 8 to Week 20 of Part B
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.
Baseline, Week 8 to Week 20 of Part B
Part B: Change from Baseline in 28-day average seizure frequency during first month of treatment
Time Frame: Baseline, Week 8 to Week 12 of Part B
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.
Baseline, Week 8 to Week 12 of Part B
Part B: Percentage of Participants with at at least 75% reduction in seizure frequency per month
Time Frame: Baseline, Week 8 to Week 20 of Part B
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.
Baseline, Week 8 to Week 20 of Part B
Part B: Percentage of Participants with seizure freedom during DB Phase
Time Frame: Week 8 to Week 20 of Part B
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.
Week 8 to Week 20 of Part B
Part B: Change from baseline in 7-day adjusted seizure frequency during first week of treatment
Time Frame: Baseline, Week 8 to Week 9 of Part B
To compare the efficacy of BHV-7000 to placebo during the first week of treatment. This objective will be measured by the change in log-transformed 7-day adjusted seizure frequency from observation phase over the first week of the double-blind phase.
Baseline, Week 8 to Week 9 of Part B
Part B: Change from baseline in Patient Global Impression of Change (PGI-C)
Time Frame: Baseline, Week 20 of Part B

To compare the efficacy of BHV-7000 to placebo on the patient global impression of change (PGI-C). This objective will be measured by proportion of subjects at week 12 of double-blind treatment phase with a PGI-C response of "minimally improved", "much improved" or "very much improved". This scale is a 7-point Likert scale with response options of:

(1) "very much improved" , (2) "much improved", (3) "minimally improved", (4) "no change", (5) "minimally worse", (6) "much worse", (7) and "very much worse"
Baseline, Week 20 of Part B
Part B: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time Frame: Week 8 to Week 20 of Part B
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.
Week 8 to Week 20 of Part B
Part B: Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Week 8 to Week 20 of Part B
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.
Week 8 to Week 20 of Part B

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biohaven Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BHV7000-302
  • 2023-508539-30 (Registry Identifier: EU CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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