Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
NCT06132893

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

Led by Biohaven Therapeutics Ltd. · Updated on 2026-05-01

390

Participants Needed

124

Research Sites

141 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female participants aged 18 to 75 years at the time of consent
  • Diagnosis of focal onset epilepsy for at least 1 year based on 2017 ILAE classification and Epilepsy Adjudication criteria
  • Focal seizures including focal aware seizures with observable signs, focal impaired awareness seizures, or focal to bilateral tonic-clonic seizures
  • Meets 2009 ILAE definition of drug-resistant epilepsy with failure of two adequate anti-seizure medication trials
  • Ability to keep accurate seizure diaries
  • Currently treated with at least 1 and up to 3 anti-seizure medications, with a maximum of 4 epilepsy treatments in total
Not Eligible

You will not qualify if you...

  • History of status epilepticus lasting over 5 minutes (convulsive) or over 10 minutes (focal with impaired consciousness) within 6 months before screening, unless consistent with habitual seizures
  • History of repetitive or cluster seizures where individual seizures cannot be counted within 6 months before screening and during observation phase
  • Neurosurgery for seizures less than 4 months before screening
  • Radiosurgery within 2 years before screening
  • Only having focal aware nonmotor seizures involving subjective sensory or psychic symptoms without impaired consciousness
  • Any condition interfering with study compliance, posing unacceptable risk, or confounding study data, as judged by the Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 124 locations

1

Barrow Neurological Institute

Phoenix, Arizona, United States, 85013

Actively Recruiting

2

Center for Neurosciences

Tucson, Arizona, United States, 85718

Actively Recruiting

3

Clinical Trials, Inc.

Little Rock, Arkansas, United States, 72205

Actively Recruiting

4

WRN

Rogers, Arkansas, United States, 72758

Withdrawn

5

University of California San Diego

La Jolla, California, United States, 92041

Actively Recruiting

6

University of California, Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

7

Stanford Health Care

Palo Alto, California, United States, 94304

Actively Recruiting

8

Profound Research LLC

Pasadena, California, United States, 91105

Actively Recruiting

9

University of Colorado Anschultz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

10

Yale School of Medicine - Yale-New Haven Hospital

New Haven, Connecticut, United States, 06519

Actively Recruiting

11

EZR Research LLC

Boca Raton, Florida, United States, 33486

Actively Recruiting

12

Nova Clinical Research, LLC

Bradenton, Florida, United States, 34209

Actively Recruiting

13

University of Florida (Jacksonville)

Jacksonville, Florida, United States, 32209

Actively Recruiting

14

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

15

Floridian Research Institute

Miami, Florida, United States, 33179

Withdrawn

16

AdventHealth Orlando

Orlando, Florida, United States, 32804

Withdrawn

17

Medsol Clinical Research Center

Port Charlotte, Florida, United States, 33952

Actively Recruiting

18

Santos Research Center

Tampa, Florida, United States, 33615

Actively Recruiting

19

Encore Medical Research of Weston LLC.

Weston, Florida, United States, 33331

Actively Recruiting

20

Pediatrix Medical Group of Florida

Winter Park, Florida, United States, 32789

Withdrawn

21

Augusta University

Augusta, Georgia, United States, 30912

Actively Recruiting

22

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States, 96817

Actively Recruiting

23

Consultants in Epilepsy & Neurology, PLLC

Boise, Idaho, United States, 83702

Actively Recruiting

24

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

25

Revive Research Institute, Inc.

Elgin, Illinois, United States, 60123

Actively Recruiting

26

Accellacare

Ames, Iowa, United States, 50010

Withdrawn

27

Bluegrass Epilepsy Research

Lexington, Kentucky, United States, 40504

Actively Recruiting

28

MAESC

Bethesda, Maryland, United States, 20817

Actively Recruiting

29

Javara

Silver Spring, Maryland, United States, 20901

Completed

30

Revive Research Institute, Inc.

Rochester Hills, Michigan, United States, 48307

Withdrawn

31

Minnesota Epilepsy Group, P.A.

Roseville, Minnesota, United States, 55113

Actively Recruiting

32

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

33

NEREG

Hackensack, New Jersey, United States, 07601

Actively Recruiting

34

Inst of Neurology

Livingston, New Jersey, United States, 07039

Actively Recruiting

35

Dent Neurosciences Research Center

Amherst, New York, United States, 14226

Actively Recruiting

36

BCHP

Hawthorne, New York, United States, 10532

Actively Recruiting

37

Northwell Health

New York, New York, United States, 10021

Actively Recruiting

38

Icahn School of Medicine at Mt. Sinai

New York, New York, United States, 10029

Withdrawn

39

Stony Brook Medicine

Stony Brook, New York, United States, 11794

Actively Recruiting

40

Five Towns Neuroscience Research

Woodmere, New York, United States, 11598

Actively Recruiting

41

OnSite Clinical Solutions

Charlotte, North Carolina, United States, 28211

Withdrawn

42

Accellacare

Mooresville, North Carolina, United States, 28117

Withdrawn

43

Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

44

NeuroScience Research Center

Canton, Ohio, United States, 44718

Actively Recruiting

45

University of Cincinnati

Cincinnati, Ohio, United States, 45267

Actively Recruiting

46

OSU

Columbus, Ohio, United States, 43214

Actively Recruiting

47

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

48

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

49

UPMC

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

50

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

51

Clinical Research Solutions LLC

Cypress, Texas, United States, 77433

Withdrawn

52

Neurology Consultants of Dallas, PA

Dallas, Texas, United States, 75243

Actively Recruiting

53

Tarrant Neurology Consultants

Fort Worth, Texas, United States, 76104

Not Yet Recruiting

54

Michael E. DeBakey VA Medical Center

Houston, Texas, United States, 77030

Withdrawn

55

UT Health San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

56

Road Runner Research, Ltd

San Antonio, Texas, United States, 78249

Actively Recruiting

57

University of Utah

Salt Lake City, Utah, United States, 84132

Actively Recruiting

58

UVM MC

Burlington, Vermont, United States, 05401

Withdrawn

59

University of Virginia

Charlottesville, Virginia, United States, 22903

Actively Recruiting

60

Henrico Doctors Neurology Associates, LLC

Richmond, Virginia, United States, 23235

Actively Recruiting

61

Carilion Clinic

Roanoke, Virginia, United States, 24011

Actively Recruiting

62

STAT Research S.A.

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1013AAB

Actively Recruiting

63

Hospital General de Agudos Dr. José María Ramos Mejia

Balvanera, Ciudad Autónoma de BuenosAires, Argentina, C1221ADC

Actively Recruiting

64

Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1431FWO

Actively Recruiting

65

Hospital Británico de Buenos Aires

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1437JCH

Actively Recruiting

66

Investigaciones Sanatorio Del Sur

San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL

Actively Recruiting

67

Sanatorio de la Trinidad - Mitre

Buenos Aires, Argentina, C1039AAO

Actively Recruiting

68

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina, C1181ACH

Actively Recruiting

69

Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI

Buenos Aires, Argentina, C1428AQK

Actively Recruiting

70

Instituto Privado Kremer

Córdoba, Argentina, X5004AOA

Actively Recruiting

71

Conci Carpinella - Santa Rosa N° 748

Córdoba, Argentina, X5008HHW

Actively Recruiting

72

Kepler Universitätsklinikum Linz - Med Campus III

Linz, Upper Austria, Austria, 4020

Actively Recruiting

73

Christian Doppler-Klinik - Universitätsklinikum der PMU

Salzburg, Austria, 5020

Actively Recruiting

74

Universitätsklinikum St. Pölten

Sankt Pölten, Austria, 3100

Actively Recruiting

75

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, Austria, 1090

Actively Recruiting

76

UZ Antwerpen

Edegem, Antwerpen, Belgium, 2650

Actively Recruiting

77

Hôpital Erasme

Anderlecht, Brussels Capital, Belgium, 1070

Actively Recruiting

78

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium, 1200

Actively Recruiting

79

CHU UCL Namur - Site Godinne

Yvoir, Namur, Belgium, 5530

Actively Recruiting

80

UZ Gent

Ghent, Oost-Vlaanderen, Belgium, 9000

Actively Recruiting

81

Centro de especialidades médicas Vanguardia

Temuco, Araucania, Chile, 4780000

Actively Recruiting

82

Hospital Padre Hurtado

Santiago, Región-MetropolitanadeSantiago, Chile, 8260094

Actively Recruiting

83

BIOCINETIC Ltda

Santiago, Región-MetropolitanadeSantiago, Chile, 8320000

Actively Recruiting

84

Centro de Investigacion Clinica UC

Santiago, Región-MetropolitanadeSantiago, Chile, 8320000

Actively Recruiting

85

Instituto Neurologico Thalamus

Viña del Mar, Valparaiso, Chile, 2520021

Actively Recruiting

86

Clinical Hospital Sveti duh

Zagreb, City of Zagreb, Croatia, 10000

Actively Recruiting

87

Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29

Zagreb, City of Zagreb, Croatia, 10000

Actively Recruiting

88

Clinical Hospital Center Rijeka - PPDS

Rijeka, Croatia, 51000

Actively Recruiting

89

Fakultni nemocnice v Motole

Prague, Praha, Hlavní Mesto, Czechia, 150 06

Actively Recruiting

90

Fakultni nemocnice u sv. Anny v Brne

Brno, South Moravian, Czechia, 602 00

Actively Recruiting

91

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, Bas-Rhin, France, 67000

Not Yet Recruiting

92

CHU Dijon Bourgogne

Dijon, Côte-d'Or, France, 21000

Actively Recruiting

93

CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan

Toulouse, Haute-Garonne, France, 31059

Actively Recruiting

94

CHU de Montpellier- Hôpital Gui De Chauliac

Montpellier, Hérault, France, 34295

Actively Recruiting

95

CHRU de Tours - Hôpital Bretonneau

Tours, Indre-et-Loire, France, 37000

Actively Recruiting

96

CHRU Nancy

Nancy, Meurthe-et-Moselle, France, 54000

Actively Recruiting

97

CHU de Lille - Hopital Claude Huriez

Lille, Nord, France, 59037

Actively Recruiting

98

Hospices Civils de Lyon - 59 Bd Pinel

Lyon, Rhône, France, 69003

Actively Recruiting

99

Hôpital Pontchaillou

Rennes, France, 35033

Actively Recruiting

100

Pécsi Tudományegyetem Klinikai Kozpont -Ret u.

Pécs, Baranya, Hungary, 7623

Actively Recruiting

101

Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus

Debrecen, Hajdú-Bihar, Hungary, 4031

Actively Recruiting

102

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, Hungary, 1106

Actively Recruiting

103

SE INK Juhasz Pal Epilepszia Központ

Budapest, Hungary, 1145

Not Yet Recruiting

104

Kempenhaeghe - PPDS

Heeze, North Brabant, Netherlands, 5591 VE

Actively Recruiting

105

Stichting Epilepsie Instellingen Nederland - Heemstede

Heemstede, North Holland, Netherlands, 2103 SW

Actively Recruiting

106

Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20

Zwolle, Overijssel, Netherlands, 8025 BV

Actively Recruiting

107

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Poznan, Greater Poland Voivodeship, Poland, 60-702

Actively Recruiting

108

Przychodnia VISTAMED

Wroclaw, Lower Silesian Voivodeship, Poland, 53-149

Actively Recruiting

109

Clinical Best Solutions - Lublin

Lublin, Lublin Voivodeship, Poland, 20-078

Actively Recruiting

110

NZOZ IGNIS dr med. Alicja Lobinska

Świdnik, Lublin Voivodeship, Poland, 21-040

Actively Recruiting

111

Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o

Nowa Sól, Lubusz Voivodeship, Poland, 67-100

Actively Recruiting

112

Santa Familia PTG Lodz

Lodz, Lódzkie, Poland, 90-302

Actively Recruiting

113

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland, 02-172

Actively Recruiting

114

Neurosphera SP. Z O.O

Warsaw, Masovian Voivodeship, Poland, 02-829

Actively Recruiting

115

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, Poland, 02-957

Actively Recruiting

116

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland, 80-546

Actively Recruiting

117

Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6

Gdansk, Poland, 80-803

Actively Recruiting

118

Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44

Katowice, Poland, 40-594

Actively Recruiting

119

Pratia MCM Kraków

Krakow, Poland, 30-727

Actively Recruiting

120

LANDA Specjalistyczne Gabinety Lekarskie

Krakow, Poland, 31-156

Actively Recruiting

121

University Clinical Centre Maribor

Maribor, Slovenia, 2000

Actively Recruiting

122

InnoMed Clinical Trial Centre

Cape Town, Western Cape, South Africa, 7530

Actively Recruiting

123

Groote Schuur Hospital

Cape Town, Western Cape, South Africa, 7700

Actively Recruiting

124

Klinik Lengg AG

Zurich, Zürich (de), Switzerland, 8008

Actively Recruiting

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Research Team

C

Chief Medical Officer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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