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NCT06443463Enrolling by invitationPhase 2

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

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy

Status (registry)
Enrolling by invitation
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
660 (estimated)
First submitted
30 May 2024
Start date
30 Jul 2024
Primary completion date
31 Dec 2026
Lead sponsor
Biohaven Therapeutics Ltd.
Diseases
Epilepsy
NCT number
NCT06443463
EU CT number
2023-508813-18-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 660
  • From 30 Jul 2024 to the primary completion date, 31 Dec 2026
  • 280 sites in 27 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (280)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital General de Agudos Dr. José María Ramos Mejia
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BalvaneraArgentinaUnknown status
Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102
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Buenos AiresArgentinaUnknown status
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
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Buenos AiresArgentinaUnknown status
Hospital Britanico de Buenos Aires
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Buenos AiresArgentinaUnknown status
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaUnknown status
Sanatorio de la Trinidad - Mitre
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Buenos AiresArgentinaUnknown status
Stat Research S.A.
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Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Instituto Privado Kremer
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CórdobaArgentinaUnknown status
Conci Carpinella - Santa Rosa N° 748
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CórdobaArgentinaUnknown status
Investigaciones Sanatorio Del Sur
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San Miguel de TucumánArgentinaUnknown status
Johannes Kepler University Linz
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LinzAustriaRecruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
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SalzburgAustriaRecruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Flinders Medical Centre
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Bedford ParkAustraliaUnknown status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
St Vincents Hospital Melbourne - PPDS
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FitzroyAustraliaUnknown status
Austin Health
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HeidelbergAustraliaUnknown status
Royal Brisbane & Women s Hospital
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HerstonAustraliaUnknown status
The Alfred Hospital
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MelbourneAustraliaUnknown status
Royal Melbourne Hospital
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ParkvilleAustraliaUnknown status
Prince of Wales Hospital
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RandwickAustraliaUnknown status
Hopital Erasme
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AnderlechtBelgiumRecruiting
Antwerp University Hospital
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EdegemBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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YvoirBelgiumRecruiting
Klinik Lengg AG
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ZurichSwitzerlandUnknown status
Centro de Investigacion Clinica UC
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SantiagoChileUnknown status
Hospital Padre Hurtado
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SantiagoChileUnknown status
Biocinetic Ltda
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SantiagoChileUnknown status
Centro de especialidades médicas Vanguardia
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TemucoChileUnknown status
Instituto Neurologico Thalamus
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Viña del MarChileUnknown status
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaRecruiting
Fakultni nemocnice v Motole
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PragueCzechiaRecruiting
Vivantes Netzwerk fuer Gesundheit GmbH
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BerlinGermanyRecruiting
Gesellschaft Fuer Epilepsieforschung
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BielefeldGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
Diakonie Kork
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KehlGermanyRecruiting
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyRecruiting
Philipps-Universitaet Marburg
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MarburgGermanyRecruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyRecruiting
Klinikum Osnabrueck GmbH
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OsnabrueckGermanyRecruiting
Epilepsiezentrum Kleinwachau gGmbH
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RadebergGermanyRecruiting
ZfP Südwürttemberg
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RavensburgGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Region Midtjylland
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Aarhus NDenmarkRecruiting
Filadelfia
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DianalundDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Hospital Germans Trias i Pujol
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BadalonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitario Clínico San Cecilio
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GranadaSpainRecruiting
Hospital Vithas La Salud
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GranadaSpainRecruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainRecruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital Ruber Internacional
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MadridSpainRecruiting
Hospital Blua Sanitas Valdebebas
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MadridSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Centro De Neurologia Avanzada S.L.P.
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SevillaSpainRecruiting
Fundacio Assistencial De Mutua De Terrassa Fpc
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TerrassaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainRecruiting
Hospital Alvaro Cunqueiro
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VigoSpainRecruiting
HUS-Yhtymae
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HelsinkiFinlandRecruiting
Pohjois-Savon hyvinvointialue
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KuopioFinlandRecruiting
Tampere University Hospital
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TampereFinlandRecruiting
Hospices Civils de Lyon
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BronFranceRecruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceRecruiting
CHRU De Nancy
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Nancy CedexFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceRecruiting
University Hospital of Wales
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CardiffUnited KingdomUnknown status
Queen Elizabeth University Hospital - PPDS
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GlasgowUnited KingdomUnknown status
The Walton Centre - PPDS
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LiverpoolUnited KingdomUnknown status
St Georges NHS Foundation Trust
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LondonUnited KingdomUnknown status
King's College Hospital
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LondonUnited KingdomUnknown status
The Royal London Hospital
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LondonUnited KingdomUnknown status
Royal Free Hospital
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LondonUnited KingdomUnknown status
Royal Victoria Infirmary
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Newcastle upon TyneUnited KingdomUnknown status
John Radcliffe Hospital
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OxfordUnited KingdomUnknown status
Salford Royal Hospital - PPDS
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SalfordUnited KingdomUnknown status
Morriston Hospital
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SwanseaUnited KingdomUnknown status
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceRecruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceRecruiting
University General Hospital of Ioannina
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IoanninaGreeceRecruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceRecruiting
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceRecruiting
Klinicki bolnicki centar Sestre milosrdnice
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Grad ZagrebCroatiaCompleted
Clinical Hospital Centre Rijeka
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RijekaCroatiaCompleted
University Hospital Sveti Duh
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ZagrebCroatiaCompleted
University Hospital Centre Zagreb
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ZagrebCroatiaCompleted
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
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BudapestHungaryRecruiting
Semmelweis University
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Budapest XIVHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
University of Pecs
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PécsHungaryRecruiting
Nizam's Insti. of Medical Sciences
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HyderabadIndiaUnknown status
Mallikatta Neuro Centre
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MangaloreIndiaUnknown status
Jaslok Hospital and Research
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MumbaiIndiaUnknown status
Dr G M Taori Memorial CIIMS
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NagpurIndiaUnknown status
All India Institute of Medical Sciences(AIIMS)
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New DelhiIndiaUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyRecruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyRecruiting
Azienda Ospedaliero Universitaria Renato Dulbecco
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CatanzaroItalyRecruiting
Universita' Degli Studi G. D'Annunzio Di Chieti
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Chieti ScaloItalyRecruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyRecruiting
IRCCS Istituto Giannina Gaslini
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GenoaItalyRecruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
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MilanItalyRecruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyRecruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
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NaplesItalyRecruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyRecruiting
Istituto Neurologico Mediterraneo Neuromed S.p.A.
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PozzilliItalyRecruiting
Ospedale Pediatrico Bambino Gesù
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RomeItalyRecruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyRecruiting
Clinstile, S.A. de C.V.
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Mexico CityMexicoUnknown status
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
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Mexico CityMexicoUnknown status
Accelerium, S. de R.L. de C.V. - PPDS
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MonterreyMexicoUnknown status
Axis Heilsa S. de R.L. de C.V.
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ObispadoMexicoUnknown status
Neurociencias Estudios Clinicos S.C.
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SinaloaMexicoUnknown status
Clinical Research Institute SC-Mexico
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TlalnepantlaMexicoUnknown status
Faicic S de RL de CV
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VeracruzMexicoUnknown status
Epilepsie Instellingen Nederland Stichting
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HeemstedeNetherlandsRecruiting
Kempenhaeghe
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HeezeNetherlandsRecruiting
Epilepsie Instellingen Nederland Stichting
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ZwolleNetherlandsRecruiting
Pratia S.A.
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CracowPolandRecruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandRecruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandRecruiting
Novo-Med Zielinski I Wspolnicy Sp. j.
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KatowicePolandRecruiting
LANDA Specjalistyczne Gabinety Lekarskie
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KrakowPolandRecruiting
Santa SP. z o.o
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LodzPolandRecruiting
Clinical Best Solutions Sp. z o.o. S.K.
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LublinPolandRecruiting
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
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Nowa SolPolandRecruiting
Synexus Polska Sp z o o
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PoznanPolandRecruiting
NZOZ IGNIS dr med. Alicja Łobinska
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ŚwidnikPolandRecruiting
Neurosphera SP. Z O.O
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WarsawPolandRecruiting
MTZ Clinical Research powered by Pratia
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WarsawPolandRecruiting
Instytut Psychiatrii I Neurologii
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WarsawPolandRecruiting
Vistamed & Vertigo Sp Z O O
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WroclawPolandRecruiting
Premium Clinic Wrocław CM
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WrocławPolandRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalRecruiting
Unidade Local De Saude De Lisboa Ocidental E.P.E.
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LisbonPortugalRecruiting
Hospital da Luz Torres de Lisboa
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LisbonPortugalRecruiting
Hospital Pedro Hispano
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MatosinhosPortugalRecruiting
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
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Santa Maria Da FeiraPortugalRecruiting
Spitalul Universitar de Urgență București
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BucharestRomaniaRecruiting
Spitalul Clinic Judetean de Urgenta Targu Mures
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Târgu MureşRomaniaRecruiting
Univerzitetni klinični center Maribor
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MariborSloveniaRecruiting
IN MEDIC, s.r.o.
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BardejovSlovakiaRecruiting
Penta hospitals SK, a.s.
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Rimavská SobotaSlovakiaRecruiting
McFarland Clinic
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AmesUnited StatesUnknown status
Dent Neurosciences Research Center
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AmherstUnited StatesUnknown status
Augusta University
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AugustaUnited StatesUnknown status
Kaiser Permanente
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AuroraUnited StatesUnknown status
University of Colorado Anschultz Medical Campus
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AuroraUnited StatesUnknown status
John Hopkins University
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BaltimoreUnited StatesUnknown status
DelRicht Research
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Baton RougeUnited StatesUnknown status
OLOLRMC
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Baton RougeUnited StatesUnknown status
Mid-Atlantic Epilepsy & Sleep Center, LLC
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BethesdaUnited StatesUnknown status
Accel Research
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BirminghamUnited StatesUnknown status
EZR Research LLC
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Boca RatonUnited StatesUnknown status
Consultants in Epilepsy & Neurology, PLLC
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BoiseUnited StatesUnknown status
Boston Clinical Trials
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BostonUnited StatesUnknown status
Nova Clinical Research, LLC
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UVM MC
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UNC- Chapel Hill
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Amicis Research Center
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Floridian Research Institute
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Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
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Serenity Research Center
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MiamiUnited StatesUnknown status
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Tri Valley Neurology Medical Associates, Inc.
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Yale School of Medicine - Yale-New Haven Hospital
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University Medical Center New Orleans
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Delricht Research
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New OrleansUnited StatesUnknown status
NYU Langone Health
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New YorkUnited StatesUnknown status
NYU
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New YorkUnited StatesUnknown status
Research Institute of Orlando
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OrlandoUnited StatesUnknown status
Comprehensive Neurology Clinic
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OrlandoUnited StatesUnknown status
AdventHealth Orlando
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OrlandoUnited StatesUnknown status
Stanford University
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Palo AltoUnited StatesUnknown status
Profound Research LLC
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PasadenaUnited StatesUnknown status
Accelerated Clinical Trials, LLC
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Peachtree CornersUnited StatesUnknown status
Panhandle Research & Medical Clinic
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PensacolaUnited StatesUnknown status
Onyx Clinical Trials
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PeoriaUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
University of Arizona/Banner University Medical Center Phoenix
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PhoenixUnited StatesUnknown status
Xenoscience Inc.
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PhoenixUnited StatesUnknown status
ARENSIA Exploratory Medicine
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PhoenixUnited StatesUnknown status
Barrow Neurological Institute
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PhoenixUnited StatesUnknown status
UPMC
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PittsburghUnited StatesUnknown status
AHN
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PittsburghUnited StatesUnknown status
Stryde Research
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PlanoUnited StatesUnknown status
SRI International
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PlymouthUnited StatesUnknown status
Medsol Clinical Research Center
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Port CharlotteUnited StatesUnknown status
Profound Research LLC
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PowayUnited StatesUnknown status
Henrico Doctors Neurology Associates, LLC
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RichmondUnited StatesUnknown status
Carilion Clinic
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RoanokeUnited StatesUnknown status
Revive Research Institute, Inc.
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Rochester HillsUnited StatesUnknown status
Knight Neurology
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RockledgeUnited StatesUnknown status
WRN
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RogersUnited StatesUnknown status
Minnesota Epilepsy Group, P.A.
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RosevilleUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
UT Health San Antonio
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San AntonioUnited StatesUnknown status
Road Runner Research, Ltd
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San AntonioUnited StatesUnknown status
LSU Health Shreveport
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ShreveportUnited StatesUnknown status
Javara
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Silver SpringUnited StatesUnknown status
Boston Neuro Research
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South DartmouthUnited StatesUnknown status
Oregon Neurology Associates
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SpringfieldUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Stony Brook Medicine
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Stony BrookUnited StatesUnknown status
PENS
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TampaUnited StatesUnknown status
Santos Research Center
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TampaUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Center for Neurosciences
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TucsonUnited StatesUnknown status
Encore Medical Research of Weston, LLC
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WestonUnited StatesUnknown status
Wake Forest Baptist
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Winston-SalemUnited StatesUnknown status
Pediatrix Medical Group of Florida
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Winter ParkUnited StatesUnknown status
Five Towns Neuroscience Research
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WoodmereUnited StatesUnknown status
Groote Schuur Hospital
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Cape TownSouth AfricaUnknown status
InnoMed Clinical Trial Centre
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Cape TownSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.