A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures

Last updated: October 1, 2025
Sponsor: Biohaven Therapeutics Ltd.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Epilepsy (Pediatric)

Epilepsy

Seizure Disorders

Treatment

BHV-7000

Placebo

Clinical Study ID

NCT06425159
BHV7000-304
2023-508812-45-00
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and Female participants 18 to 75 years of age at time of consent.

  • Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to thescreening visit, defined by 2017 International League Against Epilepsy (ILAE)Classification and based on requirements of Epilepsy Adjudication criteria.

  1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizuresand either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-waveon EEG and no focal abnormality (asymmetric spike-wave fragment is allowed)AND/OR a clear history of absence seizures or myoclonic jerks

  2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC andeither Normal EEG OR Generalized epileptiform EEG abnormality with atypicalspike-wave and no focal abnormality (asymmetric spike-wave fragment isallowed).

  • Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure ofadequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.

  • Ability of subject or caregiver to keep accurate seizure diaries

  • Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsytreatments in total (e.g., each ASM is considered 1 treatment. Other epilepsytherapies including devices and diet therapy are allowed; together these othertherapies count as 1 treatment).

  • Accurate history of having at least 3 days with a GTC seizure evenly spreadthroughout the 16 weeks prior to the screening visit, such that a subject had atleast 1 day with a GTC seizure during the first 8 weeks and at least 1 day with aGTC seizure during the second 8 weeks.

Exclusion

Exclusion Criteria:

  • History of status epilepticus (convulsive status epilepticus for > 5 minutes orfocal status epilepticus with impaired conscious for > 10 minutes) within the last 6months prior to screening visit that is not consistent with the subject's habitualseizure.

  • History of repetitive/cluster GTC seizures (where individual seizures cannot becounted) within the last 6 months prior to screening visit, or havingrepetitive/cluster GTC seizures count during the screening phase.

  • Any condition that would interfere with and/or confound the interpretation of safetyor efficacy data from the study, as judged by the Investigator

Study Design

Total Participants: 242
Treatment Group(s): 2
Primary Treatment: BHV-7000
Phase: 2/3
Study Start date:
June 20, 2024
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead 2143973, New South Wales 2155400 2145
    Australia

    Active - Recruiting

  • Royal Brisbane & Women's Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Royal Brisbane & Women's Hospital

    Herston 6931014, Queensland 2152274 4029
    Australia

    Active - Recruiting

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy 2166584, Victoria 2145234 3065
    Australia

    Active - Recruiting

  • Austin Hospital

    Heidelberg 2163654, Victoria 2145234 3084
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234 3004
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital

    Parkville 2153770, Victoria 2145234 3050
    Australia

    Active - Recruiting

  • Christian Doppler-Klinik - Universitätsklinikum der PMU

    Salzburg, A-5020
    Austria

    Site Not Available

  • Christian Doppler-Klinik - Universitätsklinikum der PMU

    Salzburg 2766824, A-5020
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Vienna 2761369, 1090
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Site Not Available

  • UZ Antwerpen

    Edegem, Antwerpen 2650
    Belgium

    Site Not Available

  • UZ Antwerpen

    Edegem 2799007, Antwerpen 2650
    Belgium

    Active - Recruiting

  • CHU UCL Namur - Site Godinne

    Yvoir, Namur 5530
    Belgium

    Site Not Available

  • CHU UCL Namur - Site Godinne

    Yvoir 2783385, Namur 5530
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • UZ Gent

    Ghent 2797656, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • Clinical Hospital Dubrava

    Zagreb 3186886, City of Zagreb 3337532 10000
    Croatia

    Site Not Available

  • Clinical Hospital Sveti Duh

    Zagreb 3186886, City of Zagreb 3337532 10000
    Croatia

    Active - Recruiting

  • Clinical Hospital Dubrava

    Zagreb, Grad Zagreb 10000
    Croatia

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    Zagreb, Grad Zagreb 10000
    Croatia

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  • Helsinki University Hospital

    Helsinki, Uusimaa 00290
    Finland

    Site Not Available

  • Helsinki University Hospital

    Helsinki 658225, Uusimaa 830709 00290
    Finland

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  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, Bas-Rhin 67000
    France

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    Strasbourg 2973783, Bas-Rhin 67000
    France

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  • CHU Dijon Bourgogne

    Dijon, Côte-d'Or 21000
    France

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    Dijon 3021372, Côte-d'Or 21000
    France

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

    Toulouse, Haute-Garonne 31059
    France

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    Toulouse 2972315, Haute-Garonne 31059
    France

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  • CHRU Lille

    Lille 2998324, Nord 59037
    France

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    Lille Cedex, Nord 59037
    France

    Site Not Available

  • Hospices Civils de Lyon - 59 Bd Pinel

    Bron, Rhône 69677
    France

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  • Hospices Civils de Lyon - 59 Bd Pinel

    Bron 3029931, Rhône 69677
    France

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  • Hôpital Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • Hôpital Pontchaillou

    Rennes 2983990, 35033
    France

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  • Epilepsiezentrum Kork

    Kehl 2891951, Baden-Wurttemberg 2953481 77694
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm-Oberer Eselsberg 45

    Ulm 2820256, Baden-Wurttemberg 2953481 89081
    Germany

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  • Epilepsiezentrum Kork

    Kehl, Baden-Württemberg 77694
    Germany

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    Ulm, Baden-Württemberg 89081
    Germany

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  • Universitätsklinikum Erlangen

    Erlangen 2929567, Bavaria 2951839 91054
    Germany

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  • LMU Klinikum der Universität München - Campus Großhadern

    München 2867713, Bavaria 2951839 81377
    Germany

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    Erlangen, Bayern 91054
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    München, Bayern 81377
    Germany

    Site Not Available

  • Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16

    Frankfurt am Main 2925533, Hesse 2905330 60528
    Germany

    Active - Recruiting

  • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

    Marburg 2873759, Hesse 2905330 35043
    Germany

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  • Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16

    Frankfurt am Main, Hessen 60528
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  • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

    Marburg, Hessen 35043
    Germany

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  • Krankenhaus Mara gGmbH

    Bielefeld, Nordrhein-Westfalen 33617
    Germany

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    Bonn, Nordrhein-Westfalen 53127
    Germany

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    Bielefeld 2949186, North Rhine-Westphalia 2861876 33617
    Germany

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  • Universitätsklinikum Bonn

    Bonn 2946447, North Rhine-Westphalia 2861876 53127
    Germany

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  • Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

    Radeberg, Sachsen 01454
    Germany

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  • Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

    Radeberg 2851079, Saxony 2842566 01454
    Germany

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  • Vivantes - Humboldt Klinikum

    Berlin, 13509
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  • Epilepsie-Zentrum Bodensee

    Ravensburg, 88214
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    Ravensburg 2849802, 88214
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  • Ospedale Policlinico SS Annunziata - Chieti

    Chieti, Abruzzo 66013
    Italy

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    Chieti 3178796, Abruzzo 3183560 66013
    Italy

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  • Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini

    Catanzaro, Calabria 88100
    Italy

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    Catanzaro 2525059, Calabria 2525468 88100
    Italy

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  • AORN Antonio Cardarelli

    Napoli, Campania 80131
    Italy

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    Napoli 9031661, Campania 3181042 80131
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  • AUSL di Bologna - Ospedale Bellaria

    Bologna, Emilia-Romagna 40139
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    Bologna 3181928, Emilia-Romagna 3177401 40139
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  • IRCCS Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, Isernia 86077
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    Pozzilli 3170006, Isernia 86077
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  • Fondazione PTV Policlinico Tor Vergata

    Roma, Lazio 00133
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  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    Roma, Lazio 165
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  • Fondazione PTV Policlinico Tor Vergata

    Rome 3169070, Lazio 3174976 00133
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  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    Rome 3169070, Lazio 3174976 165
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  • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

    Genova, Liguria 16147
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  • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

    Genoa 3176219, Liguria 3174725 16147
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  • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

    Milano, Lombardia 20142
    Italy

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    Milano, Lombardia 20132
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  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    Pavia, Lombardia 27100
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    Milan 3173435, Lombardy 3174618 20142
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    Milan 3173435, Lombardy 3174618 20132
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  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    Pavia 3171366, Lombardy 3174618 27100
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  • Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

    Baggiovara, Modena 41126
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    Baggiovara 7870564, Modena 41126
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  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    Roma, 168
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  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    Roma 8957247, 168
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  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, 37126
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  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona 3164527, 37126
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  • Kempenhaeghe - PPDS

    Heeze, Noord-Brabant 5591 VE
    Netherlands

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  • Kempenhaeghe - PPDS

    Heeze 2754618, North Brabant 2749990 5591 VE
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  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-702
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    Krakow 3094802, Lesser Poland Voivodeship 858786 30-727
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  • Twoja Przychodnia-Centrum Medyczne Nowa Sol

    Nowa Sol, Lubuskie 67-100
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    Nowa Sól 3090764, Lubusz Voivodeship 3337494 67-100
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  • Santa Familia PTG Lodz

    Lódz, Lódzkie 90-302
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    Kraków, Malopolskie 30-727
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  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk 3099434, Pomeranian Voivodeship 3337496 80-546
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  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdańsk, Pomorskie 80-546
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  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    Poznań, Wielkopolskie 60-702
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  • Neurosphera SP. Z O.O Warsaw

    Warsaw 756135, 02-829
    Poland

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  • Neurosphera SP. Z O.O Warsaw

    Warszawa, 02-829
    Poland

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

    Santa Maria Da Feira, Aveiro 4520-211
    Portugal

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

    Santa Maria da Feira 6640086, Aveiro District 2742610 4520-211
    Portugal

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  • ULS de Matosinhos, EPE - Hospital Pedro Hispano

    Senhora Da Hora, Porto 4464-513
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  • ULS de Matosinhos, EPE - Hospital Pedro Hispano

    Senhora da Hora 2734140, Porto District 2735941 4464-513
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  • Centro Clínico Académico, Braga - Hospital de Braga

    Braga, 4710-243
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  • Centro Clínico Académico, Braga - Hospital de Braga

    Braga 2742032, 4710-243
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  • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3000-075
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    Coimbra 2740637, 3000-075
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  • Hospital da Luz Torres de Lisboa

    Lisboa, 1600-209
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    Lisbon 2267057, 1600-209
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  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona 8916
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  • Hospital Universitario Germans Trias i Pujol

    Badalona 3129028, Barcelona 8916
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  • Hospital Universitario de Bellvitge

    L'Hospitalet De Llobregat, Barcelona 08907
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  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat 3120619, Barcelona 08907
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  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra 36312
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    Vigo 3105976, Pontevedra 36312
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  • Hospital del Mar

    Barcelona, 08003
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    Barcelona 3128760, 08003
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  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, 29010
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  • Centro de Neurologia Avanzada

    Sevilla, 41013
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    Seville 2510911, 41013
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  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003
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  • Neuroscience Research Centre

    Fazakerley 2649610, L9 7LJ
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    Morriston 2642180, SA6 6NL
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    Salford 2638671, M6 8HD
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    Phoenix, Arizona 85015
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  • Barrow Neurological Institute

    Phoenix, Arizona 85013
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    Tucson, Arizona 85718
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    Washington, District of Columbia 20010
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    Bradenton, Florida 34209
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    Miami, Florida 33179
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    Miami, Florida 33176
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    Miami, Florida 33144
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    Orlando, Florida 32825
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    Orlando, Florida 32806
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    Weston, Florida 33331
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    Bradenton 4148708, Florida 4155751 34209
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    Orlando 4167147, Florida 4155751 32825
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  • Consultants in Epilepsy & Neurology, PLLC (CEN)

    Boise, Idaho 83702
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    Elgin, Illinois 60123
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    Site Not Available

  • OLOLRMC

    Baton Rouge 4315588, Louisiana 4331987 70808
    United States

    Site Not Available

  • University Medical Center New Orleans

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Active - Recruiting

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston 4930956, Massachusetts 6254926 02131
    United States

    Active - Recruiting

  • Revive Research Institute, Inc.

    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Revive Research Institute, Inc.

    Rochester Hills 5007402, Michigan 5001836 48307
    United States

    Site Not Available

  • Somnos Clinical Research

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Somnos Clinical Research

    Lincoln 5072006, Nebraska 5073708 68510
    United States

    Active - Recruiting

  • NEREG

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Inst of Neurology

    Livingston, New Jersey 07039
    United States

    Active - Recruiting

  • Institute of Neurology and Neurosurgery

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • NEREG

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Institute of Neurology and Neurosurgery

    Livingston 5100572, New Jersey 5101760 07039
    United States

    Active - Recruiting

  • Dent Neurosciences Research Center

    Amherst, New York 14226
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Boston Children's Health Physicians (BCHP)

    Hawthorne, New York 10532-1528
    United States

    Site Not Available

  • Northwell Health Pediatric Neurology

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Dent Neurosciences Research Center

    Amherst 5107129, New York 5128638 14226
    United States

    Active - Recruiting

  • Boston Children's Health Physicians (BCHP)

    Hawthorne 5120284, New York 5128638 10532-1528
    United States

    Active - Recruiting

  • Northwell Health Pediatric Neurology

    New Hyde Park 5128514, New York 5128638 11042
    United States

    Site Not Available

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10467
    United States

    Active - Recruiting

  • OnSite Clinical Solutions

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • OnSite Clinical Solutions

    Charlotte 4460243, North Carolina 4482348 28211
    United States

    Site Not Available

  • UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • UPMC

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • WR-ClinSearch

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • WR-ClinSearch

    Chattanooga 4612862, Tennessee 4662168 37421
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • Clinical Research Solution LLC

    Cypress, Texas 77429
    United States

    Site Not Available

  • Neurology Consultants of Dallas, PA

    Dallas, Texas 75243
    United States

    Site Not Available

  • ANESC Research

    El Paso, Texas 79912
    United States

    Site Not Available

  • UTHealth Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Road Runner Research, Ltd

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Clinical Research Solution LLC

    Cypress 4684724, Texas 4736286 77429
    United States

    Site Not Available

  • Neurology Consultants of Dallas, PA

    Dallas 4684888, Texas 4736286 75243
    United States

    Active - Recruiting

  • ANESC Research

    El Paso 5520993, Texas 4736286 79912
    United States

    Active - Recruiting

  • Road Runner Research, Ltd

    San Antonio 4726206, Texas 4736286 78249
    United States

    Active - Recruiting

  • Intermountain Health

    Murray, Utah 84107
    United States

    Site Not Available

  • Intermountain Health

    Murray 5778755, Utah 5549030 84107
    United States

    Active - Recruiting

  • Henrico Doctors' Neurology Associates, LLC

    Richmond, Virginia 23235
    United States

    Site Not Available

  • Henrico Doctors'Neurology Associates, LLC

    Richmond, Virginia 23235
    United States

    Active - Recruiting

  • Henrico Doctors' Neurology Associates, LLC

    Richmond 4781708, Virginia 6254928 23235
    United States

    Active - Recruiting

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