Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
NCT06309966

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

Led by Biohaven Therapeutics Ltd. · Updated on 2026-04-17

390

Participants Needed

174

Research Sites

102 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

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 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, focal impaired awareness, or focal to bilateral tonic-clonic seizures
  • Drug resistant epilepsy defined by failure of adequate trials of two tolerated and appropriately chosen anti-seizure medication schedules
  • Ability to keep accurate seizure diaries
  • Current treatment with at least 1 and up to 3 anti-seizure medications and no more than 4 epilepsy treatments in total
Not Eligible

You will not qualify if you...

  • History of status epilepticus lasting more than 5 minutes (convulsive) or more than 10 minutes (focal with impaired consciousness) within 6 months prior to screening not consistent with habitual seizures
  • History of repetitive or cluster seizures within 6 months prior to screening and during observation phase
  • Neurosurgery for seizures less than 4 months prior to screening
  • Radiosurgery less than 2 years prior to screening
  • Only focal aware nonmotor seizures involving subjective sensory or psychic symptoms without impaired consciousness
  • Any condition that interferes with ability to comply with study instructions or poses unacceptable risk, 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: 174 locations

1

Accel Research

Birmingham, Alabama, United States, 35244

Withdrawn

2

Onyx Clinical Trials

Peoria, Arizona, United States, 85381

Actively Recruiting

3

Xenoscience, Inc.

Phoenix, Arizona, United States, 85004

Actively Recruiting

4

University of Arizona / Banner University Medical Center Phoenix

Phoenix, Arizona, United States, 85006

Actively Recruiting

5

ARENSIA Exploratory Medicine

Phoenix, Arizona, United States, 85015

Actively Recruiting

6

Clinical Trials, Inc.

Little Rock, Arkansas, United States, 72205

Actively Recruiting

7

Amicis Research Center

Lancaster, California, United States, 93534

Withdrawn

8

Memorialcare Miller Children's & Women's Hospital Long Beach

Long Beach, California, United States, 90806

Withdrawn

9

Tri Valley Neurology Medical Associates, Inc.

Mission Hills, California, United States, 91345

Actively Recruiting

10

Stanford University

Palo Alto, California, United States, 94304

Withdrawn

11

Profound Research LLC

Poway, California, United States, 92065

Actively Recruiting

12

Kaiser Permanente

Aurora, Colorado, United States, 80011

Withdrawn

13

UConn Health

Farmington, Connecticut, United States, 06030

Actively Recruiting

14

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010

Withdrawn

15

EZR Research, LLC

Boca Raton, Florida, United States, 33486

Withdrawn

16

Nova Clinical Research, LLC

Bradenton, Florida, United States, 34209

Actively Recruiting

17

Las Mercedes Medical Research

Hialeah, Florida, United States, 33012

Actively Recruiting

18

Coral Clinic Research

Homestead, Florida, United States, 33032

Actively Recruiting

19

Dm Healthworks

Kissimmee, Florida, United States, 34741

Withdrawn

20

Y&L Advance Health Care, Inc d/b/a Elite Clinical Research

Miami, Florida, United States, 33144

Actively Recruiting

21

Serenity Research Center

Miami, Florida, United States, 33176

Actively Recruiting

22

Research Institute of Orlando

Orlando, Florida, United States, 32806

Actively Recruiting

23

Comprehensive Neurology Clinic

Orlando, Florida, United States, 32825

Actively Recruiting

24

Panhandle Research & Medical Clinic

Pensacola, Florida, United States, 32502

Actively Recruiting

25

Knight Neurology

Rockledge, Florida, United States, 32955

Actively Recruiting

26

PENS

Tampa, Florida, United States, 33609

Withdrawn

27

Encore Medical Research of Weston LLC.

Weston, Florida, United States, 33331

Actively Recruiting

28

Accelerated Clinical Trials, LLC

Peachtree Corners, Georgia, United States, 30071

Actively Recruiting

29

Bluegrass Epilepsy Research

Lexington, Kentucky, United States, 40504

Actively Recruiting

30

OLORMC

Baton Rouge, Louisiana, United States, 70808

Withdrawn

31

DelRicht Research

Baton Rouge, Louisiana, United States, 70810

Actively Recruiting

32

Neurocare Of Louisiana

Covington, Louisiana, United States, 70433

Actively Recruiting

33

University Medical Center New Orleans

New Orleans, Louisiana, United States, 70112

Actively Recruiting

34

DelRicht Research

New Orleans, Louisiana, United States, 70119

Actively Recruiting

35

LSU Health Shreveport

Shreveport, Louisiana, United States, 71103

Actively Recruiting

36

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

37

Boston Clinical Trials

Boston, Massachusetts, United States, 02131

Actively Recruiting

38

Boston Neuro Research

South Dartmouth, Massachusetts, United States, 02747

Actively Recruiting

39

SRI International

Plymouth, Michigan, United States, 48170

Actively Recruiting

40

University of Missouri Health Care

Columbia, Missouri, United States, 65212

Actively Recruiting

41

Somnos Clinical Research

Lincoln, Nebraska, United States, 68510

Actively Recruiting

42

NEREG

Hackensack, New Jersey, United States, 07601

Actively Recruiting

43

Tekton Research

Marlboro, New Jersey, United States, 07746

Actively Recruiting

44

Dent Neurosciences Research Center

Amherst, New York, United States, 14226

Actively Recruiting

45

Northwell Health

Great Neck, New York, United States, 11021

Actively Recruiting

46

Northwell Health Ped. Neurology

New Hyde Park, New York, United States, 11042

Withdrawn

47

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

48

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

49

UNC-Chapel Hill

Chapel Hill, North Carolina, United States, 27514

Withdrawn

50

Cincinatti Children's Hospital

Cincinnati, Ohio, United States, 45229

Withdrawn

51

Premier Health

Dayton, Ohio, United States, 45409

Actively Recruiting

52

Oregon Neurology Associates

Springfield, Oregon, United States, 97477

Actively Recruiting

53

AHN

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

54

MUSC

Charleston, South Carolina, United States, 29425

Actively Recruiting

55

WR-ClinSearch

Chattanooga, Tennessee, United States, 37421

Withdrawn

56

Le Bonheur Children's Hospital

Memphis, Tennessee, United States, 38103

Actively Recruiting

57

Horizon Clinical Research Group

Cypress, Texas, United States, 77429

Actively Recruiting

58

M3 Wake Research-Dallas

Dallas, Texas, United States, 75246

Actively Recruiting

59

ANESC Research

El Paso, Texas, United States, 79912

Actively Recruiting

60

Tarrant Neurology Associates

Fort Worth, Texas, United States, 76104

Withdrawn

61

UTHealth Houston

Houston, Texas, United States, 77030

Actively Recruiting

62

UTHSC

Houston, Texas, United States, 77030

Actively Recruiting

63

Stryde Research

Plano, Texas, United States, 75093

Actively Recruiting

64

Intermountain Health

Murray, Utah, United States, 84107

Actively Recruiting

65

Medstar Health Research Institute

McLean, Virginia, United States, 22101

Actively Recruiting

66

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

Actively Recruiting

67

Prince of Wales Hospital

Randwick, New South Wales, Australia, 2031

Actively Recruiting

68

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia, 4029

Actively Recruiting

69

St Vincents Hospital Melbourne - PPDS

Fitzroy, Victoria, Australia, 3065

Actively Recruiting

70

Austin Health

Heidelberg, Victoria, Australia, 3084

Actively Recruiting

71

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Actively Recruiting

72

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Actively Recruiting

73

Flinders Medical Centre

Bedford Park, Australia, 5042

Actively Recruiting

74

Odense Universitetshospital

Odense, Fyn, Denmark, 5000

Actively Recruiting

75

Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

76

Epilepsihospitalet Filadelfia

Dianalund, Denmark, 4293

Actively Recruiting

77

Kuopion yliopistollinen sairaala

Kuopio, Northern Savonia, Finland, 70200

Actively Recruiting

78

Tampereen yliopistollinen sairaala

Tampere, Pirkanmaa, Finland, 33520

Actively Recruiting

79

Helsinki University Hospital

Helsinki, Uusimaa, Finland, 00290

Actively Recruiting

80

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106

Actively Recruiting

81

Epilepsiezentrum Kork

Kehl, Baden-Wurttemberg, Germany, 77694

Actively Recruiting

82

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany, 89081

Actively Recruiting

83

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany, 91054

Actively Recruiting

84

LMU Klinikum der Universität München - Campus Großhadern

München, Bavaria, Germany, 81377

Actively Recruiting

85

Epilepsieklinik Tabor

Bernau bei Berlin, Brandenburg, Germany, 16321

Not Yet Recruiting

86

Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

Marburg, Hesse, Germany, 35043

Actively Recruiting

87

Klinikum Osnabrück GmbH

Osnabrück, Lower Saxony, Germany, 49076

Actively Recruiting

88

Krankenhaus Mara gGmbH

Bielefeld, North Rhine-Westphalia, Germany, 33617

Actively Recruiting

89

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany, 53127

Actively Recruiting

90

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany, 48149

Not Yet Recruiting

91

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany, 04103

Actively Recruiting

92

Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

Radeberg, Saxony, Germany, 01454

Actively Recruiting

93

Vivantes - Humboldt Klinikum

Berlin, Germany, 13509

Actively Recruiting

94

Universitätsklinikum Frankfurt

Frankfurt, Germany, 60590

Actively Recruiting

95

Epilepsie-Zentrum Bodensee

Ravensburg, Germany, 88214

Actively Recruiting

96

University General Hospital of Alexandroupolis

Alexandroupoli, Greece, 681 00

Actively Recruiting

97

University General Hospital ''ATTIKON''

Chaïdári, Greece, 124 62

Actively Recruiting

98

University General Hospital of Ioannina

Ioannina, Greece, 455 00

Actively Recruiting

99

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece, 546 36

Actively Recruiting

100

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, Greece, 546 36

Actively Recruiting

101

Semmel Egyet Idegsebésze Neuro Klin

Budapest, Hungary, 1145

Actively Recruiting

102

Nizam's Insti. of Medical Sciences

Hyderabad, India, 500082

Actively Recruiting

103

Mallikatta Neuro Centre

Mangalore, India, 575002

Actively Recruiting

104

Jaslok Hospital and Research

Mumbai, India, 400026

Actively Recruiting

105

Dr G M Taori Memorial CIIMS

Nagpur, India, 440010

Actively Recruiting

106

All India Institute of Medical Sciences (AIIMS)

New Delhi, India, 110029

Actively Recruiting

107

Università degli Studi G. D'Annunzio Chieti-Pescara

Chieti, Abruzzo, Italy, 66013

Actively Recruiting

108

Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini

Catanzaro, Calabria, Italy, 88100

Actively Recruiting

109

AORN Antonio Cardarelli

Naples, Campania, Italy, 80131

Actively Recruiting

110

AUSL di Bologna - Ospedale Bellaria

Bologna, Emilia-Romagna, Italy, 40123

Actively Recruiting

111

Fondazione PTV Policlinico Tor Vergata

Rome, Lazio, Italy, 00133

Actively Recruiting

112

Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

Genoa, Liguria, Italy, 16147

Actively Recruiting

113

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, Italy, 20132

Actively Recruiting

114

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy, 20133

Actively Recruiting

115

ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

Milan, Lombardy, Italy, 20142

Actively Recruiting

116

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, Italy, 27100

Actively Recruiting

117

Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

Baggiovara, Modena, Italy, 41126

Actively Recruiting

118

IRCCS Istituto Neurologico Mediterraneo Neuromed

Pozzilli, Molise, Italy, 86077

Actively Recruiting

119

Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, The Marches, Italy, 60121

Actively Recruiting

120

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

Calambrone, Tuscany, Italy, 56018

Actively Recruiting

121

Fondazione Policlinico Universitario A Gemelli-Rome

Roma, Italy, 00168

Actively Recruiting

122

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

Rome, Italy, 00165

Actively Recruiting

123

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Italy, 37126

Actively Recruiting

124

Clinstile, S.A. de C.V.

Mexico City, Mexico, 06700

Actively Recruiting

125

Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city

Mexico City, Mexico, 14050

Not Yet Recruiting

126

Accelerium, S. de R.L. de C.V. - PPDS

Monterrey, Mexico, 64000

Not Yet Recruiting

127

Axis Heilsa S. de R.L. de C.V.

Obispado, Mexico, 64060

Actively Recruiting

128

Neurociencias Estudios Clinicos S.C.

Sinaloa, Mexico, 80020

Actively Recruiting

129

Clinical Research Institute SC-Mexico

Tlalnepantla, Mexico, 54055

Actively Recruiting

130

FAICIC S De RL De CV

Veracruz, Mexico, 91900

Actively Recruiting

131

MTZ Clinical Research

Krakow, Poland, 02-172

Actively Recruiting

132

Pratia MCM Krakow

Krakow, Poland, 30-727

Actively Recruiting

133

LANDA Specjalistyczne

Krakow, Poland, 31-156

Actively Recruiting

134

Neurosphera SP. Z O.O

Warsaw, Poland, 02-829

Actively Recruiting

135

Premium Clinic Wrocław

Wroclaw, Poland, 50-414

Actively Recruiting

136

ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião

Santa Maria da Feira, Aveiro District, Portugal, 4520-211

Actively Recruiting

137

ULS de Matosinhos, EPE - Hospital Pedro Hispano

Senhora da Hora, Porto District, Portugal, 4454-509

Actively Recruiting

138

Centro Clínico Académico, Braga - Hospital de Braga

Braga, Portugal, 4710-243

Actively Recruiting

139

ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra

Coimbra, Portugal, 3000-459

Actively Recruiting

140

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, Portugal, 1449-005

Actively Recruiting

141

Hospital da Luz Torres de Lisboa

Lisbon, Portugal, 1600-209

Actively Recruiting

142

Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50

Târgu Mureş, Mureș County, Romania, 540136

Actively Recruiting

143

Emergency University Hospital

Bucharest, Romania, 11635

Actively Recruiting

144

IN MEDIC, s.r.o.

Bardejov, Slovakia, 085 01

Actively Recruiting

145

Kraskova 2636, Neurologické oddelenie

Rimavská Sobota, Slovakia, 979 01

Actively Recruiting

146

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Actively Recruiting

147

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Actively Recruiting

148

Hospital Universitario de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

149

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, Spain, 36312

Actively Recruiting

150

Hospital del Mar

Barcelona, Spain, 08003

Actively Recruiting

151

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain, 08035

Actively Recruiting

152

Fundacio Assistencial Mutua de Terrassa

Barcelona, Spain, 08221

Actively Recruiting

153

Hospital Universitario Clínico San Cecilio

Granada, Spain, 18007

Actively Recruiting

154

Hospital Vithas Granada

Granada, Spain, 18008

Actively Recruiting

155

Hospital Universitario Virgen de Las Nieves

Granada, Spain, 18013

Actively Recruiting

156

Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, Spain, 28034

Actively Recruiting

157

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain, 28040

Actively Recruiting

158

Blua Sanitas Valdebebas Hospital

Madrid, Spain, 28055

Not Yet Recruiting

159

Hospital blua sanitas valdebebas

Madrid, Spain, 28055

Actively Recruiting

160

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Spain, 29010

Actively Recruiting

161

Centro de Neurologia Avanzada

Seville, Spain, 41013

Actively Recruiting

162

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain, 46026

Actively Recruiting

163

Hospital Clinico Universitario de Valladolid

Valladolid, Spain, 47003

Actively Recruiting

164

Morriston Hospital

Swansea, Glamorgan, United Kingdom, SA6 6NL

Actively Recruiting

165

Queen Elizabeth University Hospital-PPDS

Glasgow, Glasgow City, United Kingdom, G51 4TF

Actively Recruiting

166

Salford Royal Hospital - PPDS

Salford, Manchester, United Kingdom, M6 8HD

Actively Recruiting

167

The Walton Centre - PPDS

Liverpool, Merseyside, United Kingdom, L9 7LJ

Actively Recruiting

168

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Actively Recruiting

169

University Hospital of Wales

Cardiff, South Glamorgan, United Kingdom, CF14 4XW

Actively Recruiting

170

Royal Free Hospital

London, United Kingdom, NW3 2QG

Not Yet Recruiting

171

King's College Hospital

London, United Kingdom, SE5 9RS

Actively Recruiting

172

St Georges NHS Foundation Trust

London, United Kingdom, SW17 0QT

Actively Recruiting

173

The Royal London Hospital

London, United Kingdom, WC1N 3HR

Actively Recruiting

174

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom, NE1 4LP

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

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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