Focal EpilepsyPhase 2NCT06443463
Long-term Safety and Tolerability of BHV-7000
A Phase 2 study testing BHV-7000 in people with Focal Epilepsy, run by Biohaven Therapeutics Ltd. at 283 sites in 27 countries.
Trial summary
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- BHV-7000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 283 sitesin 27 countries
- Study dates
- 30 Jul 2024to Jan 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303.
- (FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit
Who cannot join
- Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, 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.
- Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
Trial locations and contacts
283 sites in 27 countries. Contact the study team or a site near you to ask about taking part.
283 sites in 27 countries
United States115 sites
McFarland Clinic
Ames, Iowa, 50010
Dent Neurosciences Research Center
Amherst, New York, 14226
Augusta University
Augusta, Georgia, 30912
Kaiser Permanente
Aurora, Colorado, 80011
University of Colorado Anschultz Medical Campus
Aurora, Colorado, 80045
John Hopkins University
Baltimore, Maryland, 21287
OLOLRMC
Baton Rouge, Louisiana, 70808
DelRicht Research
Baton Rouge, Louisiana, 70810
Mid-Atlantic Epilepsy & Sleep Center, LLC
Bethesda, Maryland, 20817
Accel Research
Birmingham, Alabama, 35244
EZR Research LLC
Boca Raton, Florida, 33486
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702
Boston Clinical Trials
Boston, Massachusetts, 02131
Nova Clinical Research, LLC
Bradenton, Florida, 34209
UVM MC
Burlington, Vermont, 05401
NeuroScience Research Center
Canton, Ohio, 44718
UNC-Chapel Hill
Chapel Hill, North Carolina, 27514
MUSC
Charleston, South Carolina, 29425
OnSite Clinical Solutions
Charlotte, North Carolina, 28211
University of Virginia
Charlottesville, Virginia, 22903
WR-ClinSearch
Chattanooga, Tennessee, 37421
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45267
University of Missouri Health Care
Columbia, Missouri, 65212
OSU
Columbus, Ohio, 43214
Neurocare Of Louisiana
Covington, Louisiana, 70433
Horizon Clinical Research Group
Cypress, Texas, 77429
Clinical Research Solutions LLC
Cypress, Texas, 77433
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243
M3 Wake Research-Dallas
Dallas, Texas, 75246
Premier Health
Dayton, Ohio, 45409
ANESC Research
El Paso, Texas, 79912
Revive Research Institute, Inc.
Elgin, Illinois, 60123
UConn Health
Farmington, Connecticut, 06030
Tarrant Neurology Consultants
Fort Worth, Texas, 76104
Northwell Health
Great Neck, New York, 11021
NEREG
Hackensack, New Jersey, 07601
BCHP
Hawthorne, New York, 10532
Las Mercedes Medical Research
Hialeah, Florida, 33012
Coral Clinic Research
Homestead, Florida, 33032
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
UTHealth Houston
Houston, Texas, 77030
UTHSC
Houston, Texas, 77030
University of Florida (Jacksonville)
Jacksonville, Florida, 32209
Dm Healthworks
Kissimmee, Florida, 34741
University of California San Diego
La Jolla, California, 92041
Amicis Research Center
Lancaster, California, 93534
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504
Somnos Clinical Research
Lincoln, Nebraska, 68510
Clinical Trials, Inc.
Little Rock, Arkansas, 72205
Inst of Neurology
Livingston, New Jersey, 07039
Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806
University of California, Los Angeles
Los Angeles, California, 90095
Tekton Research
Marlboro, New Jersey, 07746
Medstar Health Research Institute
McLean, Virginia, 22101
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
University of Miami
Miami, Florida, 33136
Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
Miami, Florida, 33144
Serenity Research Center
Miami, Florida, 33176
Floridian Research Institute
Miami, Florida, 33179
Tri Valley Neurology Medical Associates, Inc.
Mission Hills, California, 91345
Accellacare
Mooresville, North Carolina, 28117
Intermountain Health
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Jersey Shore Medical Center
Neptune City, New Jersey, 07753
Yale School of Medicine - Yale-New Haven Hospital
New Haven, Connecticut, 06519
Northwell Health
New Hyde Park, New York, 11042
University Medical Center New Orleans
New Orleans, Louisiana, 70112
DelRicht Research
New Orleans, Louisiana, 70119
NYU Langone Health
New York, New York, 10016
NYU
New York, New York, 10016
AdventHealth Orlando
Orlando, Florida, 32804
Research Institute of Orlando
Orlando, Florida, 32806
Comprehensive Neurology Clinic
Orlando, Florida, 32825
Stanford University
Palo Alto, California, 94304
Profound Research LLC
Pasadena, California, 91105
Accelerated Clinical Trials, LLC
Peachtree Corners, Georgia, 30071
Panhandle Research & Medical Clinic
Pensacola, Florida, 32502
Onyx Clinical Trials
Peoria, Arizona, 85381
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Xenoscience, Inc.
Phoenix, Arizona, 85004
University of Arizona / Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Barrow Neurological Institute
Phoenix, Arizona, 85013
ARENSIA Exploratory Medicine
Phoenix, Arizona, 85015
AHN
Pittsburgh, Pennsylvania, 15212
UPMC
Pittsburgh, Pennsylvania, 15213
Stryde Research
Plano, Texas, 75093
SRI International
Plymouth, Michigan, 48170
Medsol Clinical Research Center
Port Charlotte, Florida, 33952
Profound Research LLC
Poway, California, 92065
Henrico Doctors Neurology Associates, LLC
Richmond, Virginia, 23235
Carilion Clinic
Roanoke, Virginia, 24011
Revive Research Institute, Inc.
Rochester Hills, Michigan, 48307
Knight Neurology
Rockledge, Florida, 32955
WRN
Rogers, Arkansas, 72758
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota, 55113
University of Utah
Salt Lake City, Utah, 84132
UT Health San Antonio
San Antonio, Texas, 78229
Road Runner Research, Ltd
San Antonio, Texas, 78249
LSU Health Shreveport
Shreveport, Louisiana, 71103
Javara
Silver Spring, Maryland, 20901
Boston Neuro Research
South Dartmouth, Massachusetts, 02747
Oregon Neurology Associates
Springfield, Oregon, 97477
Washington University School of Medicine
St Louis, Missouri, 63110
Stony Brook Medicine
Stony Brook, New York, 11794
PENS
Tampa, Florida, 33609
Santos Research Center
Tampa, Florida, 33615
Montefiore Medical Center
The Bronx, New York, 10467
Center for Neurosciences
Tucson, Arizona, 85718
Encore Medical Research of Weston LLC.
Weston, Florida, 33331
Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Pediatrix Medical Group of Florida
Winter Park, Florida, 32789
Five Towns Neuroscience Research
Woodmere, New York, 11598
Italy17 sites
Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, The Marches, 60121
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Baggiovara, Modena, 41126
AUSL di Bologna - Ospedale Bellaria
Bologna, Emilia-Romagna, 40123
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Calambrone, Tuscany, 56018
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
Catanzaro, Calabria, 88100
Università degli Studi G. D'Annunzio Chieti-Pescara
Chieti, Abruzzo, 66013
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa, Liguria, 16147
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, 20132
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, 20133
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milan, Lombardy, 20142
AORN Antonio Cardarelli
Naples, Campania, 80131
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy, 27100
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise, 86077
Fondazione Policlinico Universitario A Gemelli-Rome
Roma, 00168
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, 00165
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, 37126
Spain17 sites
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
Fundacio Assistencial Mutua de Terrassa
Barcelona, 08221
Hospital Universitario Clínico San Cecilio
Granada, 18007
Hospital Vithas Granada
Granada, 18008
Hospital Universitario Virgen de Las Nieves
Granada, 18013
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, 28034
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital blua sanitas valdebebas
Madrid, 28055
Hospital Regional Universitario de Malaga - Hospital General
Málaga, 29010
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Centro de Neurologia Avanzada
Seville, 41013
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, 36312
Germany16 sites
Vivantes - Humboldt Klinikum
Berlin, 13509
Epilepsieklinik Tabor
Bernau bei Berlin, Brandenburg, 16321
Krankenhaus Mara gGmbH
Bielefeld, North Rhine-Westphalia, 33617
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Universitätsklinikum Frankfurt
Frankfurt, 60590
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Epilepsiezentrum Kork
Kehl, Baden-Wurttemberg, 77694
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
Marburg, Hesse, 35043
LMU Klinikum der Universität München - Campus Großhadern
München, Bavaria, 81377
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Klinikum Osnabrück GmbH
Osnabrück, Lower Saxony, 49076
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
Radeberg, Saxony, 01454
Epilepsie-Zentrum Bodensee
Ravensburg, 88214
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Poland15 sites
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546
Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
Gdansk, 80-803
Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
Katowice, 40-594
Pratia MCM Kraków
Krakow, 30-727
LANDA Specjalistyczne Gabinety Lekarskie
Krakow, 31-156
Santa Familia PTG Lodz
Lodz, Lódzkie, 90-302
Clinical Best Solutions - Lublin
Lublin, Lublin Voivodeship, 20-078
Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, Lubusz Voivodeship, 67-100
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702
NZOZ IGNIS dr med. Alicja Lobinska
Świdnik, Lublin Voivodeship, 21-040
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship, 02-172
Neurosphera SP. Z O.O
Warsaw, Masovian Voivodeship, 02-829
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, 02-957
Przychodnia VISTAMED
Wroclaw, Lower Silesian Voivodeship, 53-149
Premium Clinic Wrocław
Wroclaw, 50-414
United Kingdom11 sites
University Hospital of Wales
Cardiff, South Glamorgan, CF14 4XW
Queen Elizabeth University Hospital-PPDS
Glasgow, Glasgow City, G51 4TF
The Walton Centre - PPDS
Liverpool, Merseyside, L9 7LJ
Royal Free Hospital
London, NW3 2QG
King's College Hospital
London, SE5 9RS
St Georges NHS Foundation Trust
London, SW17 0QT
The Royal London Hospital
London, WC1N 3HR
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Salford Royal Hospital - PPDS
Salford, Manchester, M6 8HD
Morriston Hospital
Swansea, Glamorgan, SA6 6NL
Argentina10 sites
Hospital General de Agudos Dr. José María Ramos Mejia
Balvanera, Ciudad Autónoma de BuenosAires, C1221ADC
Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102
Buenos Aires, Ciudad Autónoma de BuenosAires, C1431FWO
Hospital Británico de Buenos Aires
Buenos Aires, Ciudad Autónoma de BuenosAires, C1437JCH
Sanatorio de la Trinidad - Mitre
Buenos Aires, C1039AAO
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
Buenos Aires, C1428AQK
STAT Research S.A.
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1013AAB
Instituto Privado Kremer
Córdoba, X5004AOA
Conci Carpinella - Santa Rosa N° 748
Córdoba, X5008HHW
Investigaciones Sanatorio Del Sur
San Miguel de Tucumán, Tucumán Province, T4000AXL
France9 sites
CHU Dijon Bourgogne
Dijon, Côte-d'Or, 21000
CHU de Lille - Hopital Claude Huriez
Lille, Nord, 59037
Hospices Civils de Lyon - 59 Bd Pinel
Lyon, Rhône, 69003
CHU de Montpellier- Hôpital Gui De Chauliac
Montpellier, Hérault, 34295
CHRU Nancy
Nancy, Meurthe-et-Moselle, 54000
Hôpital Pontchaillou
Rennes, 35033
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, Bas-Rhin, 67000
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
Toulouse, Haute-Garonne, 31059
CHRU de Tours - Hôpital Bretonneau
Tours, Indre-et-Loire, 37000
Australia8 sites
Flinders Medical Centre
Bedford Park, 5042
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
St Vincents Hospital Melbourne - PPDS
Fitzroy, Victoria, 3065
Austin Health
Heidelberg, Victoria, 3084
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029
The Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Parkville, Victoria, 3050
Prince of Wales Hospital
Randwick, New South Wales, 2031
Mexico7 sites
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
Mexico City, 14050
Clinstile, S.A. de C.V.
Mexico City, 6700
Accelerium, S. de R.L. de C.V. - PPDS
Monterrey, 64000
Axis Heilsa S. de R.L. de C.V.
Obispado, 64060
Neurociencias Estudios Clinicos S.C.
Sinaloa, 80020
Clinical Research Institute SC-Mexico
Tlalnepantla, 54055
FAICIC S De RL De CV
Veracruz, 91900
Portugal6 sites
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3000-459
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, 1449-005
Hospital da Luz Torres de Lisboa
Lisbon, 1600-209
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
Santa Maria da Feira, Aveiro District, 4520-211
ULS de Matosinhos, EPE - Hospital Pedro Hispano
Senhora da Hora, Porto District, 4454-509
Belgium5 sites
Hôpital Erasme
Anderlecht, Brussels Capital, 1070
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200
UZ Antwerpen
Edegem, Antwerpen, 2650
UZ Gent
Ghent, Oost-Vlaanderen, 9000
CHU UCL Namur - Site Godinne
Yvoir, Namur, 5530
Chile5 sites
Hospital Padre Hurtado
Santiago, Región-MetropolitanadeSantiago, 8260094
BIOCINETIC Ltda
Santiago, Región-MetropolitanadeSantiago, 8320000
Centro de Investigacion Clinica UC
Santiago, Región-MetropolitanadeSantiago, 8320000
Centro de especialidades médicas Vanguardia
Temuco, Araucania, 4780000
Instituto Neurologico Thalamus
Viña del Mar, Valparaiso, 2520021
Croatia5 sites
Clinical Hospital Center Rijeka - PPDS
Rijeka, 51000
Clinical Hospital Dubrava
Zagreb, City of Zagreb, 10000
Clinical Hospital Sveti duh
Zagreb, City of Zagreb, 10000
Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
Zagreb, City of Zagreb, 10000
Klinicki bolnicki centar Zagreb
Zagreb, City of Zagreb, 10000
Greece5 sites
University General Hospital of Alexandroupolis
Alexandroupoli, 681 00
University General Hospital ''ATTIKON''
Chaïdári, 124 62
University General Hospital of Ioannina
Ioannina, 455 00
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, 546 36
India5 sites
Nizam's Insti. of Medical Sciences
Hyderabad, 500082
Mallikatta Neuro Centre
Mangalore, 575002
Jaslok Hospital and Research
Mumbai, 400026
Dr G M Taori Memorial CIIMS
Nagpur, 440010
All India Institute of Medical Sciences (AIIMS)
New Delhi, 110029
Austria4 sites
Kepler Universitätsklinikum Linz - Med Campus III
Linz, Upper Austria, 4020
Christian Doppler-Klinik - Universitätsklinikum der PMU
Salzburg, 5020
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, 1090
Hungary4 sites
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106
SE INK Juhasz Pal Epilepszia Központ
Budapest, 1145
Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
Debrecen, Hajdú-Bihar, 4031
Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
Pécs, Baranya, 7623
Denmark3 sites
Aarhus University Hospital
Aarhus, 8200
Epilepsihospitalet Filadelfia
Dianalund, 4293
Odense Universitetshospital
Odense, Fyn, 5000
Finland3 sites
Helsinki University Hospital
Helsinki, Uusimaa, 00290
Kuopion yliopistollinen sairaala
Kuopio, Northern Savonia, 70200
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, 33520
Netherlands3 sites
Stichting Epilepsie Instellingen Nederland - Heemstede
Heemstede, North Holland, 2103 SW
Kempenhaeghe - PPDS
Heeze, North Brabant, 5591 VE
Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
Zwolle, Overijssel, 8025 BV
Czechia2 sites
Fakultni nemocnice u sv. Anny v Brne
Brno, South Moravian, 602 00
Fakultni nemocnice v Motole
Prague, Praha, Hlavní Mesto, 150 06
Romania2 sites
Emergency University Hospital
Bucharest, 11635
Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50
Târgu Mureş, Mureș County, 540136
Slovakia2 sites
IN MEDIC, s.r.o.
Bardejov, 085 01
Kraskova 2636, Neurologické oddelenie
Rimavská Sobota, 979 01
South Africa2 sites
InnoMed Clinical Trial Centre
Cape Town, Western Cape, 7530
Groote Schuur Hospital
Cape Town, Western Cape, 7700
About this study
Official title: A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
- Conditions
- Focal Epilepsy
- Being tested
- BHV-7000
- Keywords
- Focal Epilepsy, Epilepsy, Seizure, Refractory Epilepsy, Partial Epilepsy
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Seizures, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-7000Drug
BHV-7000 50 mg. Participants will take open-label investigational product (IP) once daily
BHV-7000Drug
BHV-7000 75 mg. Participants will take open-label investigational product (IP) once daily
| Study group | Role | What they receive |
|---|---|---|
| BHV-7000 50 mg | Experimental | Not described Receives: Drug: BHV-7000 |
| BHV-7000 75 mg | Experimental | Not described Receives: Drug: BHV-7000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 104 weeks
Number of Subjects 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 or 4 laboratory abnormalities.
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start30 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443463
- Sponsor's protocol ID
- BHV7000-201
- Other IDs
- 2023-508813-18-00, 2023
- Status last verified
- Apr 2026
- First submitted
- 30 May 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No