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NCT06425159CompletedPhase 2/3

Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures – SHINE

A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects with Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures, with Open-label Extension

Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Sept 2025

Brief summary (registry, in English)

To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with IGE with GTC as measured by the time to the second day with a GTC seizure during the double-blind phase.

Status (registry)
Completed
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
122 (actual)
First submitted
14 Jun 2024
Start date
11 Nov 2024
Lead sponsor
Biohaven Therapeutics Ltd.
Diseases
Epilepsy
NCT number
NCT06425159
EU CT number
2023-508812-45-00

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 122
  • 60 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (60)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Uniklinikum Salzburg, Christian-Doppler-Klinik
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SalzburgAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
Antwerp University Hospital
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EdegemBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Coordinator of this site? Confirm its status
YvoirBelgiumCompleted
Vivantes Netzwerk fuer Gesundheit GmbH
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Gesellschaft Fuer Epilepsieforschung
Coordinator of this site? Confirm its status
BielefeldGermanyCompleted
Universitaetsklinikum Bonn AöR
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BonnGermanyCompleted
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyCompleted
Goethe University Frankfurt
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Frankfurt Am MainGermanyCompleted
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyCompleted
Diakonie Kork
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KehlGermanyCompleted
Philipps-Universitaet Marburg
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MarburgGermanyCompleted
Klinikum der Universitaet Muenchen AöR
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MunichGermanyCompleted
Epilepsiezentrum Kleinwachau gGmbH
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RadebergGermanyCompleted
Zentrum für Psychiatrie Südwürttemberg Epilepsy Centre Bodensee
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RavensburgGermanyCompleted
Universitaetsklinikum Ulm AoR
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UlmGermanyCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
Centro De Neurologia Avanzada S.L.P.
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SevillaSpainCompleted
Hospital Clínico Universitario de Valladolid
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ValladolidSpainCompleted
Hospital Alvaro Cunqueiro
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VigoSpainCompleted
HUS-Yhtymae
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HelsinkiFinlandCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Centre Hospitalier Universitaire de Dijon
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DijonFranceCompleted
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Clinical Hospital Dubrava
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Grad ZagrebCroatiaCompleted
University Hospital Sveti Duh
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ZagrebCroatiaCompleted
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyCompleted
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyCompleted
Azienda Ospedaliero Universitaria Renato Dulbecco
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CatanzaroItalyCompleted
Universita' Degli Studi G. D'Annunzio Di Chieti
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Chieti ScaloItalyCompleted
IRCCS Istituto Giannina Gaslini
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GenoaItalyCompleted
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
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MilanItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyCompleted
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
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NaplesItalyCompleted
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyCompleted
Istituto Neurologico Mediterraneo Neuromed S.p.A.
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PozzilliItalyCompleted
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Ospedale Pediatrico Bambino Gesù
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RomeItalyCompleted
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyCompleted
Kempenhaeghe
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HeezeNetherlandsCompleted
Pratia S.A.
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CracowPolandCompleted
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandCompleted
Santa SP. z o.o
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LodzPolandCompleted
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
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Nowa SolPolandCompleted
Synexus Polska Sp z o o
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PoznanPolandCompleted
Neurosphera SP. Z O.O
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WarsawPolandCompleted
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalCompleted
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalCompleted
Hospital da Luz Torres de Lisboa
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LisbonPortugalCompleted
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
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Santa Maria Da FeiraPortugalCompleted
Unidade Local De Saude De Matosinhos E.P.E.
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Senhora Da HoraPortugalCompleted

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