Long-term Safety and Tolerability of BHV-7000
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
2 other identifiers
interventional
660
25 countries
274
Brief Summary
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2024
274 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 5, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
May 1, 2026
April 1, 2026
2.3 years
May 30, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Up to 104 weeks
Study Arms (2)
BHV-7000 50 mg
EXPERIMENTALBHV-7000 75 mg
EXPERIMENTALInterventions
BHV-7000 50 mg. Participants will take open-label investigational product (IP) once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (283)
Accel Research
Birmingham, Alabama, 35244, United States
Onyx Clinical Trials
Peoria, Arizona, 85381, United States
Xenoscience, Inc.
Phoenix, Arizona, 85004, United States
University of Arizona / Banner University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
ARENSIA Exploratory Medicine
Phoenix, Arizona, 85015, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Clinical Trials, Inc.
Little Rock, Arkansas, 72205, United States
WRN
Rogers, Arkansas, 72758, United States
University of California San Diego
La Jolla, California, 92041, United States
Amicis Research Center
Lancaster, California, 93534, United States
Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Tri Valley Neurology Medical Associates, Inc.
Mission Hills, California, 91345, United States
Stanford University
Palo Alto, California, 94304, United States
Profound Research LLC
Pasadena, California, 91105, United States
Profound Research LLC
Poway, California, 92065, United States
Kaiser Permanente
Aurora, Colorado, 80011, United States
University of Colorado Anschultz Medical Campus
Aurora, Colorado, 80045, United States
UConn Health
Farmington, Connecticut, 06030, United States
Yale School of Medicine - Yale-New Haven Hospital
New Haven, Connecticut, 06519, United States
EZR Research LLC
Boca Raton, Florida, 33486, United States
Nova Clinical Research, LLC
Bradenton, Florida, 34209, United States
Las Mercedes Medical Research
Hialeah, Florida, 33012, United States
Coral Clinic Research
Homestead, Florida, 33032, United States
University of Florida (Jacksonville)
Jacksonville, Florida, 32209, United States
Dm Healthworks
Kissimmee, Florida, 34741, United States
University of Miami
Miami, Florida, 33136, United States
Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
Miami, Florida, 33144, United States
Serenity Research Center
Miami, Florida, 33176, United States
Floridian Research Institute
Miami, Florida, 33179, United States
AdventHealth Orlando
Orlando, Florida, 32804, United States
Research Institute of Orlando
Orlando, Florida, 32806, United States
Comprehensive Neurology Clinic
Orlando, Florida, 32825, United States
Panhandle Research & Medical Clinic
Pensacola, Florida, 32502, United States
Medsol Clinical Research Center
Port Charlotte, Florida, 33952, United States
Knight Neurology
Rockledge, Florida, 32955, United States
PENS
Tampa, Florida, 33609, United States
Santos Research Center
Tampa, Florida, 33615, United States
Encore Medical Research of Weston LLC.
Weston, Florida, 33331, United States
Pediatrix Medical Group of Florida
Winter Park, Florida, 32789, United States
Augusta University
Augusta, Georgia, 30912, United States
Accelerated Clinical Trials, LLC
Peachtree Corners, Georgia, 30071, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702, United States
Northwestern University
Chicago, Illinois, 60611, United States
Revive Research Institute, Inc.
Elgin, Illinois, 60123, United States
McFarland Clinic
Ames, Iowa, 50010, United States
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504, United States
OLOLRMC
Baton Rouge, Louisiana, 70808, United States
DelRicht Research
Baton Rouge, Louisiana, 70810, United States
Neurocare Of Louisiana
Covington, Louisiana, 70433, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
DelRicht Research
New Orleans, Louisiana, 70119, United States
LSU Health Shreveport
Shreveport, Louisiana, 71103, United States
John Hopkins University
Baltimore, Maryland, 21287, United States
Mid-Atlantic Epilepsy & Sleep Center, LLC
Bethesda, Maryland, 20817, United States
Javara
Silver Spring, Maryland, 20901, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Boston Neuro Research
South Dartmouth, Massachusetts, 02747, United States
SRI International
Plymouth, Michigan, 48170, United States
Revive Research Institute, Inc.
Rochester Hills, Michigan, 48307, United States
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota, 55113, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Somnos Clinical Research
Lincoln, Nebraska, 68510, United States
NEREG
Hackensack, New Jersey, 07601, United States
Inst of Neurology
Livingston, New Jersey, 07039, United States
Tekton Research
Marlboro, New Jersey, 07746, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
Northwell Health
Great Neck, New York, 11021, United States
BCHP
Hawthorne, New York, 10532, United States
Northwell Health
New Hyde Park, New York, 11042, United States
NYU Langone Health
New York, New York, 10016, United States
NYU
New York, New York, 10016, United States
Stony Brook Medicine
Stony Brook, New York, 11794, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Five Towns Neuroscience Research
Woodmere, New York, 11598, United States
UNC-Chapel Hill
Chapel Hill, North Carolina, 27514, United States
OnSite Clinical Solutions
Charlotte, North Carolina, 28211, United States
Accellacare
Mooresville, North Carolina, 28117, United States
Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
NeuroScience Research Center
Canton, Ohio, 44718, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
OSU
Columbus, Ohio, 43214, United States
Premier Health
Dayton, Ohio, 45409, United States
Oregon Neurology Associates
Springfield, Oregon, 97477, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
AHN
Pittsburgh, Pennsylvania, 15212, United States
UPMC
Pittsburgh, Pennsylvania, 15213, United States
MUSC
Charleston, South Carolina, 29425, United States
WR-ClinSearch
Chattanooga, Tennessee, 37421, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Horizon Clinical Research Group
Cypress, Texas, 77429, United States
Clinical Research Solutions LLC
Cypress, Texas, 77433, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243, United States
M3 Wake Research-Dallas
Dallas, Texas, 75246, United States
ANESC Research
El Paso, Texas, 79912, United States
Tarrant Neurology Consultants
Fort Worth, Texas, 76104, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
UTHealth Houston
Houston, Texas, 77030, United States
UTHSC
Houston, Texas, 77030, United States
Stryde Research
Plano, Texas, 75093, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
Road Runner Research, Ltd
San Antonio, Texas, 78249, United States
Intermountain Health
Murray, Utah, 84107, United States
University of Utah
Salt Lake City, Utah, 84132, United States
UVM MC
Burlington, Vermont, 05401, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Medstar Health Research Institute
McLean, Virginia, 22101, United States
Henrico Doctors Neurology Associates, LLC
Richmond, Virginia, 23235, United States
Carilion Clinic
Roanoke, Virginia, 24011, United States
STAT Research S.A.
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1013AAB, Argentina
Hospital General de Agudos Dr. José María Ramos Mejia
Balvanera, Ciudad Autónoma de BuenosAires, C1221ADC, Argentina
Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102
Buenos Aires, Ciudad Autónoma de BuenosAires, C1431FWO, Argentina
Hospital Británico de Buenos Aires
Buenos Aires, Ciudad Autónoma de BuenosAires, C1437JCH, Argentina
Investigaciones Sanatorio Del Sur
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Sanatorio de la Trinidad - Mitre
Buenos Aires, C1039AAO, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH, Argentina
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
Buenos Aires, C1428AQK, Argentina
Instituto Privado Kremer
Córdoba, X5004AOA, Argentina
Conci Carpinella - Santa Rosa N° 748
Córdoba, X5008HHW, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
St Vincents Hospital Melbourne - PPDS
Fitzroy, Victoria, 3065, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Flinders Medical Centre
Bedford Park, 5042, Australia
Kepler Universitätsklinikum Linz - Med Campus III
Linz, Upper Austria, 4020, Austria
Christian Doppler-Klinik - Universitätsklinikum der PMU
Salzburg, 5020, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, 3100, Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, 1090, Austria
UZ Antwerpen
Edegem, Antwerpen, 2650, Belgium
Hôpital Erasme
Anderlecht, Brussels Capital, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200, Belgium
CHU UCL Namur - Site Godinne
Yvoir, Namur, 5530, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
Centro de especialidades médicas Vanguardia
Temuco, Araucania, 4780000, Chile
Hospital Padre Hurtado
Santiago, Región-MetropolitanadeSantiago, 8260094, Chile
BIOCINETIC Ltda
Santiago, Región-MetropolitanadeSantiago, 8320000, Chile
Centro de Investigacion Clinica UC
Santiago, Región-MetropolitanadeSantiago, 8320000, Chile
Instituto Neurologico Thalamus
Viña del Mar, Valparaiso, 2520021, Chile
Clinical Hospital Dubrava
Zagreb, City of Zagreb, 10000, Croatia
Clinical Hospital Sveti duh
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Zagreb
Zagreb, City of Zagreb, 10000, Croatia
Clinical Hospital Center Rijeka - PPDS
Rijeka, 51000, Croatia
Fakultni nemocnice v Motole
Prague, Praha, Hlavní Mesto, 150 06, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, South Moravian, 602 00, Czechia
Odense Universitetshospital
Odense, Fyn, 5000, Denmark
Aarhus University Hospital
Aarhus, 8200, Denmark
Epilepsihospitalet Filadelfia
Dianalund, 4293, Denmark
Kuopion yliopistollinen sairaala
Kuopio, Northern Savonia, 70200, Finland
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, 33520, Finland
Helsinki University Hospital
Helsinki, Uusimaa, 00290, Finland
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, Bas-Rhin, 67000, France
CHU Dijon Bourgogne
Dijon, Côte-d'Or, 21000, France
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
Toulouse, Haute-Garonne, 31059, France
CHU de Montpellier- Hôpital Gui De Chauliac
Montpellier, Hérault, 34295, France
CHRU de Tours - Hôpital Bretonneau
Tours, Indre-et-Loire, 37000, France
CHRU Nancy
Nancy, Meurthe-et-Moselle, 54000, France
CHU de Lille - Hopital Claude Huriez
Lille, Nord, 59037, France
Hospices Civils de Lyon - 59 Bd Pinel
Lyon, Rhône, 69003, France
Hôpital Pontchaillou
Rennes, 35033, France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Epilepsiezentrum Kork
Kehl, Baden-Wurttemberg, 77694, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
LMU Klinikum der Universität München - Campus Großhadern
München, Bavaria, 81377, Germany
Epilepsieklinik Tabor
Bernau bei Berlin, Brandenburg, 16321, Germany
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
Marburg, Hesse, 35043, Germany
Klinikum Osnabrück GmbH
Osnabrück, Lower Saxony, 49076, Germany
Krankenhaus Mara gGmbH
Bielefeld, North Rhine-Westphalia, 33617, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
Radeberg, Saxony, 01454, Germany
Vivantes - Humboldt Klinikum
Berlin, 13509, Germany
Universitätsklinikum Frankfurt
Frankfurt, 60590, Germany
Epilepsie-Zentrum Bodensee
Ravensburg, 88214, Germany
University General Hospital of Alexandroupolis
Alexandroupoli, 681 00, Greece
University General Hospital ''ATTIKON''
Chaïdári, 124 62, Greece
University General Hospital of Ioannina
Ioannina, 455 00, Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36, Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, 546 36, Greece
Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
Pécs, Baranya, 7623, Hungary
Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
Debrecen, Hajdú-Bihar, 4031, Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106, Hungary
SE INK Juhasz Pal Epilepszia Központ
Budapest, 1145, Hungary
Nizam's Insti. of Medical Sciences
Hyderabad, 500082, India
Mallikatta Neuro Centre
Mangalore, 575002, India
Jaslok Hospital and Research
Mumbai, 400026, India
Dr G M Taori Memorial CIIMS
Nagpur, 440010, India
All India Institute of Medical Sciences (AIIMS)
New Delhi, 110029, India
Università degli Studi G. D'Annunzio Chieti-Pescara
Chieti, Abruzzo, 66013, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
Catanzaro, Calabria, 88100, Italy
AORN Antonio Cardarelli
Naples, Campania, 80131, Italy
AUSL di Bologna - Ospedale Bellaria
Bologna, Emilia-Romagna, 40123, Italy
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa, Liguria, 16147, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, 20132, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, 20133, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milan, Lombardy, 20142, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy, 27100, Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Baggiovara, Modena, 41126, Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise, 86077, Italy
Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, The Marches, 60121, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Calambrone, Tuscany, 56018, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
Roma, 00168, Italy
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, 00165, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, 37126, Italy
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
Mexico City, 14050, Mexico
Clinstile, S.A. de C.V.
Mexico City, 6700, Mexico
Accelerium, S. de R.L. de C.V. - PPDS
Monterrey, 64000, Mexico
Axis Heilsa S. de R.L. de C.V.
Obispado, 64060, Mexico
Neurociencias Estudios Clinicos S.C.
Sinaloa, 80020, Mexico
Clinical Research Institute SC-Mexico
Tlalnepantla, 54055, Mexico
FAICIC S De RL De CV
Veracruz, 91900, Mexico
Kempenhaeghe - PPDS
Heeze, North Brabant, 5591 VE, Netherlands
Stichting Epilepsie Instellingen Nederland - Heemstede
Heemstede, North Holland, 2103 SW, Netherlands
Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
Zwolle, Overijssel, 8025 BV, Netherlands
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702, Poland
Przychodnia VISTAMED
Wroclaw, Lower Silesian Voivodeship, 53-149, Poland
Clinical Best Solutions - Lublin
Lublin, Lublin Voivodeship, 20-078, Poland
NZOZ IGNIS dr med. Alicja Lobinska
Świdnik, Lublin Voivodeship, 21-040, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Santa Familia PTG Lodz
Lodz, Lódzkie, 90-302, Poland
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship, 02-172, Poland
Neurosphera SP. Z O.O
Warsaw, Masovian Voivodeship, 02-829, Poland
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, 02-957, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
Gdansk, 80-803, Poland
Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
Katowice, 40-594, Poland
Pratia MCM Kraków
Krakow, 30-727, Poland
LANDA Specjalistyczne Gabinety Lekarskie
Krakow, 31-156, Poland
Premium Clinic Wrocław
Wroclaw, 50-414, Poland
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
Santa Maria da Feira, Aveiro District, 4520-211, Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano
Senhora da Hora, Porto District, 4454-509, Portugal
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3000-459, Portugal
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, 1449-005, Portugal
Hospital da Luz Torres de Lisboa
Lisbon, 1600-209, Portugal
Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50
Târgu Mureş, Mureș County, 540136, Romania
Emergency University Hospital
Bucharest, 11635, Romania
IN MEDIC, s.r.o.
Bardejov, 085 01, Slovakia
Kraskova 2636, Neurologické oddelenie
Rimavská Sobota, 979 01, Slovakia
University Clinical Centre Maribor
Maribor, 2000, Slovenia
InnoMed Clinical Trial Centre
Cape Town, Western Cape, 7530, South Africa
Groote Schuur Hospital
Cape Town, Western Cape, 7700, South Africa
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, 31008, Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035, Spain
Fundacio Assistencial Mutua de Terrassa
Barcelona, 08221, Spain
Hospital Universitario Clínico San Cecilio
Granada, 18007, Spain
Hospital Vithas Granada
Granada, 18008, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18013, Spain
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital blua sanitas valdebebas
Madrid, 28055, Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, 29010, Spain
Centro de Neurologia Avanzada
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47003, Spain
Klinik Lengg AG
Zurich, Zürich (de), 8008, Switzerland
Morriston Hospital
Swansea, Glamorgan, SA6 6NL, United Kingdom
Queen Elizabeth University Hospital-PPDS
Glasgow, Glasgow City, G51 4TF, United Kingdom
Salford Royal Hospital - PPDS
Salford, Manchester, M6 8HD, United Kingdom
The Walton Centre - PPDS
Liverpool, Merseyside, L9 7LJ, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
University Hospital of Wales
Cardiff, South Glamorgan, CF14 4XW, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
St Georges NHS Foundation Trust
London, SW17 0QT, United Kingdom
The Royal London Hospital
London, WC1N 3HR, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 5, 2024
Study Start
July 30, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04