Long-term Safety and Tolerability of BHV-7000

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

July 30, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

January 31, 2027

Conditions
Focal Epilepsy
Interventions
DRUG

BHV-7000

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

DRUG

BHV-7000

BHV-7000 75 mg. Participants will take open-label investigational product (IP) once daily

Trial Locations (265)

1070

Hôpital Erasme, Anderlecht

1090

Medizinische Universitat Wien (Medical University of Vienna), Vienna

1106

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest

1145

SE INK Juhasz Pal Epilepszia Központ, Budapest

1200

Cliniques Universitaires Saint-Luc, Brussels

2000

University Clinical Centre Maribor, Maribor

2031

Prince of Wales Hospital, Randwick

2050

Royal Prince Alfred Hospital, Camperdown

2650

UZ Antwerpen, Edegem

3004

The Alfred Hospital, Melbourne

3050

Royal Melbourne Hospital, Parkville

3065

St Vincents Hospital Melbourne - PPDS, Fitzroy

3084

Austin Health, Heidelberg

3100

Universitätsklinikum St. Pölten, Sankt Pölten

4020

Kepler Universitätsklinikum Linz - Med Campus III, Linz

4029

Royal Brisbane & Women's Hospital, Herston

4031

Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus, Debrecen

5000

Odense Universitetshospital, Odense

5020

Christian Doppler-Klinik - Universitätsklinikum der PMU, Salzburg

5042

Flinders Medical Centre, Bedford Park

5530

CHU UCL Namur - Site Godinne, Yvoir

6700

Clinstile, S.A. de C.V., Mexico City

7530

InnoMed Clinical Trial Centre, Cape Town

7623

Pécsi Tudományegyetem Klinikai Kozpont -Ret u., Pécs

7700

Groote Schuur Hospital, Cape Town

8008

Klinik Lengg AG, Zurich

9000

UZ Gent, Ghent

10000

Clinical Hospital Dubrava, Zagreb

Clinical Hospital Sveti duh, Zagreb

Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29, Zagreb

Klinicki bolnicki centar Zagreb, Zagreb

10016

NYU Langone Health, New York

NYU, New York

10467

Montefiore Medical Center, The Bronx

10532

BCHP, Hawthorne

11021

Northwell Health, Great Neck

11042

Northwell Health, New Hyde Park

11598

Five Towns Neuroscience Research, Woodmere

11635

Emergency University Hospital, Bucharest

11794

Stony Brook Medicine, Stony Brook

13509

Vivantes - Humboldt Klinikum, Berlin

14050

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

14226

Dent Neurosciences Research Center, Amherst

15212

AHN, Pittsburgh

15213

UPMC, Pittsburgh

16147

Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN, Genoa

16321

Epilepsieklinik Tabor, Bernau bei Berlin

18007

Hospital Universitario Clínico San Cecilio, Granada

18008

Hospital Vithas Granada, Granada

18013

Hospital Universitario Virgen de Las Nieves, Granada

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

20132

Ospedale San Raffaele S.r.l. - PPDS, Milan

20133

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

20142

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

20817

Mid-Atlantic Epilepsy & Sleep Center, LLC, Bethesda

20901

Javara, Silver Spring

21000

CHU Dijon Bourgogne, Dijon

21287

John Hopkins University, Baltimore

22101

Medstar Health Research Institute, McLean

22903

University of Virginia, Charlottesville

23235

Henrico Doctors Neurology Associates, LLC, Richmond

24011

Carilion Clinic, Roanoke

27100

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS, Pavia

27157

Wake Forest Baptist, Winston-Salem

27514

UNC-Chapel Hill, Chapel Hill

28034

Hospital Ruber Internacional (Grupo Quironsalud), Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28117

Accellacare, Mooresville

28211

OnSite Clinical Solutions, Charlotte

29010

Hospital Regional Universitario de Malaga - Hospital General, Málaga

29425

MUSC, Charleston

30071

Accelerated Clinical Trials, LLC, Peachtree Corners

30912

Augusta University, Augusta

31008

Hospital Universitario de Navarra, Pamplona

31059

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

32209

University of Florida (Jacksonville), Jacksonville

32502

Panhandle Research & Medical Clinic, Pensacola

32789

Pediatrix Medical Group of Florida, Winter Park

32804

AdventHealth Orlando, Orlando

32806

Research Institute of Orlando, Orlando

32825

Comprehensive Neurology Clinic, Orlando

32955

Knight Neurology, Rockledge

33012

Las Mercedes Medical Research, Hialeah

33032

Coral Clinic Research, Homestead

33136

University of Miami, Miami

33144

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

33176

Serenity Research Center, Miami

33179

Floridian Research Institute, Miami

33331

Encore Medical Research of Weston LLC., Weston

33486

EZR Research LLC, Boca Raton

33520

Tampereen yliopistollinen sairaala, Tampere

33609

PENS, Tampa

33615

Santos Research Center, Tampa

33617

Krankenhaus Mara gGmbH, Bielefeld

33952

Medsol Clinical Research Center, Port Charlotte

34209

Nova Clinical Research, LLC, Bradenton

34295

CHU de Montpellier- Hôpital Gui De Chauliac, Montpellier

34741

Dm Healthworks, Kissimmee

35033

Hôpital Pontchaillou, Rennes

35043

Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg, Marburg

35244

Accel Research, Birmingham

36312

CHUVI - H.U. Alvaro Cunqueiro, Vigo

37000

CHRU de Tours - Hôpital Bretonneau, Tours

37126

Azienda Ospedaliera Universitaria Integrata Di Verona, Verona

37232

Vanderbilt University Medical Center, Nashville

37421

WR-ClinSearch, Chattanooga

38103

Le Bonheur Children's Hospital, Memphis

40123

AUSL di Bologna - Ospedale Bellaria, Bologna

40504

Bluegrass Epilepsy Research, Lexington

41013

Centro de Neurologia Avanzada, Seville

41126

Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara, Baggiovara

43214

OSU, Columbus

44718

NeuroScience Research Center, Canton

45267

University of Cincinnati, Cincinnati

45409

Wright State University, Dayton

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

47003

Hospital Clinico Universitario de Valladolid, Valladolid

48149

Universitätsklinikum Münster, Münster

48170

SRI International, Plymouth

48307

Revive Research Institute, Inc., Rochester Hills

49076

Klinikum Osnabrück GmbH, Osnabrück

50010

McFarland Clinic, Ames

51000

Clinical Hospital Center Rijeka - PPDS, Rijeka

53127

Universitätsklinikum Bonn, Bonn

54000

CHRU Nancy, Nancy

54055

Clinical Research Institute SC-Mexico, Tlalnepantla

55113

Minnesota Epilepsy Group, P.A., Roseville

56018

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN, Calambrone

59037

CHU de Lille - Hopital Claude Huriez, Lille

60121

Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona

60123

Revive Research Institute, Inc., Elgin

60590

Universitätsklinikum Frankfurt, Frankfurt

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, St Louis

64000

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

64060

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

66013

Università degli Studi G. D'Annunzio Chieti-Pescara, Chieti

67000

CHU de Strasbourg - Hôpital de Hautepierre, Strasbourg

68510

Somnos Clinical Research, Lincoln

69003

Hospices Civils de Lyon - 59 Bd Pinel, Lyon

70112

University Medical Center New Orleans, New Orleans

70119

DelRicht Research, New Orleans

70200

Kuopion yliopistollinen sairaala, Kuopio

70433

Neurocare Of Louisiana, Covington

70808

OLOLRMC, Baton Rouge

70810

DelRicht Research, Baton Rouge

71103

LSU Health Shreveport, Shreveport

72205

Clinical Trials, Inc., Little Rock

72758

WRN, Rogers

75093

Stryde Research, Plano

75243

Neurology Consultants of Dallas, PA, Dallas

75246

M3 Wake Research-Dallas, Dallas

76104

Tarrant Neurology Consultants, Fort Worth

77030

Michael E. DeBakey VA Medical Center, Houston

UTHealth Houston, Houston

UTHSC, Houston

77429

Horizon Clinical Research Group, Cypress

77433

Clinical Research Solutions LLC, Cypress

77694

Epilepsiezentrum Kork, Kehl

78229

UT Health San Antonio, San Antonio

78249

Road Runner Research, Ltd, San Antonio

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

79912

ANESC Research, El Paso

80011

Kaiser Permanente, Aurora

80020

Neurociencias Estudios Clinicos S.C., Sinaloa

80045

University of Colorado Anschultz Medical Campus, Aurora

80131

AORN Antonio Cardarelli, Napoli

81377

LMU Klinikum der Universität München - Campus Großhadern, München

83702

Consultants in Epilepsy & Neurology, PLLC, Boise

84107

Intermountain Health, Murray

84132

University of Utah, Salt Lake City

85004

Xenoscience, Inc., Phoenix

85013

Barrow Neurological Institute, Phoenix

85015

ARENSIA Exploratory Medicine, Phoenix

85381

Onyx Clinical Trials, Peoria

85718

Center for Neurosciences, Tucson

86077

IRCCS Istituto Neurologico Mediterraneo Neuromed, Pozzilli

88100

Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini, Catanzaro

88214

Epilepsie-Zentrum Bodensee, Ravensburg

89081

Universitätsklinikum Ulm, Ulm

90095

University of California, Los Angeles, Los Angeles

90806

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

91054

Universitätsklinikum Erlangen, Erlangen

91105

Profound Research LLC, Pasadena

91345

Tri Valley Neurology Medical Associates, Inc., Mission Hills

91900

FAICIC S De RL De CV, Veracruz

92041

University of California San Diego, La Jolla

92065

Profound Research LLC, Poway

93534

Amicis Research Center, Lancaster

94304

Stanford University, Palo Alto

96817

Hawaii Pacific Neuroscience, Honolulu

97477

Oregon Neurology Associates, Springfield

540136

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

2520021

Instituto Neurologico Thalamus, Viña del Mar

4780000

Centro de especialidades médicas Vanguardia, Temuco

8260094

Hospital Padre Hurtado, Santiago

8320000

BIOCINETIC Ltda, Santiago

Centro de Investigacion Clinica UC, Santiago

06030

UConn Health, Farmington

06519

Yale School of Medicine - Yale-New Haven Hospital, New Haven

02131

Boston Clinical Trials, Boston

07601

NEREG, Hackensack

07039

Inst of Neurology, Livingston

07753

Jersey Shore Medical Center, Neptune City

05401

UVM MC, Burlington

C1013AAB

STAT Research S.A., Ciudad Autónoma de Buenos Aires

C1221ADC

Hospital General de Agudos Dr. José María Ramos Mejia, Balvanera

C1431FWO

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

C1437JCH

Hospital Británico de Buenos Aires, Buenos Aires

T4000AXL

Investigaciones Sanatorio Del Sur, San Miguel de Tucumán

C1181ACH

Hospital Italiano de Buenos Aires, Buenos Aires

C1428AQK

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

X5004AOA

Instituto Privado Kremer, Córdoba

X5008HHW

Conci Carpinella - Santa Rosa N° 748, Córdoba

150 06

Fakultni nemocnice v Motole, Prague

602 00

Fakultni nemocnice u sv. Anny v Brne, Brno

00290

Helsinki University Hospital, Helsinki

04103

Universitätsklinikum Leipzig, Leipzig

01454

Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh, Radeberg

681 00

University General Hospital of Alexandroupolis, Alexandroupoli

124 62

University General Hospital ''ATTIKON'', Chaïdári

455 00

University General Hospital of Ioannina, Ioannina

546 36

AHEPA University General Hospital of Thessaloniki, Thessaloniki

Georgios Papanikolaou General Hospital of Thessaloniki, Thessaloniki

00133

Fondazione PTV Policlinico Tor Vergata, Rome

00168

Fondazione Policlinico Universitario A Gemelli-Rome, Roma

00165

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN, Rome

5591 VE

Kempenhaeghe - PPDS, Heeze

2103 SW

Stichting Epilepsie Instellingen Nederland - Heemstede, Heemstede

8025 BV

Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20, Zwolle

60-702

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

53-149

Przychodnia VISTAMED, Wroclaw

20-078

Clinical Best Solutions - Lublin, Lublin

21-040

NZOZ IGNIS dr med. Alicja Lobinska, Świdnik

67-100

Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o, Nowa Sól

90-302

Santa Familia PTG Lodz, Lodz

02-172

MTZ Clinical Research Powered by PRATIA - PPDS, Warsaw

02-829

Neurosphera SP. Z O.O, Warsaw

02-957

Instytut Psychiatrii i Neurologii, Warsaw

80-546

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

80-803

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

40-594

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

30-727

Pratia MCM Kraków, Krakow

31-156

LANDA Specjalistyczne Gabinety Lekarskie, Krakow

4520-211

ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião, Santa Maria da Feira

4454-509

ULS de Matosinhos, EPE - Hospital Pedro Hispano, Senhora da Hora

4710-243

Centro Clínico Académico, Braga - Hospital de Braga, Braga

3000-459

ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra, Coimbra

1449-005

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz, Lisbon

1600-209

Hospital da Luz Torres de Lisboa, Lisbon

085 01

IN MEDIC, s.r.o., Bardejov

979 01

Kraskova 2636, Neurologické oddelenie, Rimavská Sobota

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

08003

Hospital del Mar, Barcelona

08035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

SA6 6NL

Morriston Hospital, Swansea

G51 4TF

Queen Elizabeth University Hospital-PPDS, Glasgow

M6 8HD

Salford Royal Hospital - PPDS, Salford

L9 7LJ

The Walton Centre - PPDS, Liverpool

WC1N 3BG

University College Hospital, London

OX3 9DU

John Radcliffe Hospital, Oxford

CF14 4XW

University Hospital of Wales, Cardiff

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Biohaven Therapeutics Ltd.

INDUSTRY