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
Sites (60)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniklinikum Salzburg, Christian-Doppler-Klinik Coordinator of this site? Confirm its status | Salzburg | Austria | Completed |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Completed |
| Vivantes Netzwerk fuer Gesundheit GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Gesellschaft Fuer Epilepsieforschung Coordinator of this site? Confirm its status | Bielefeld | Germany | Completed |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Completed |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Completed |
| Diakonie Kork Coordinator of this site? Confirm its status | Kehl | Germany | Completed |
| Philipps-Universitaet Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Epilepsiezentrum Kleinwachau gGmbH Coordinator of this site? Confirm its status | Radeberg | Germany | Completed |
| Zentrum für Psychiatrie Südwürttemberg Epilepsy Centre Bodensee Coordinator of this site? Confirm its status | Ravensburg | Germany | Completed |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Centro De Neurologia Avanzada S.L.P. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Completed |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Completed |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| Clinical Hospital Dubrava Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Completed |
| University Hospital Sveti Duh Coordinator of this site? Confirm its status | Zagreb | Croatia | Completed |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Completed |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Azienda Ospedaliero Universitaria Renato Dulbecco Coordinator of this site? Confirm its status | Catanzaro | Italy | Completed |
| Universita' Degli Studi G. D'Annunzio Di Chieti Coordinator of this site? Confirm its status | Chieti Scalo | Italy | Completed |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Completed |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Istituto Neurologico Mediterraneo Neuromed S.p.A. Coordinator of this site? Confirm its status | Pozzilli | Italy | Completed |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Completed |
| Kempenhaeghe Coordinator of this site? Confirm its status | Heeze | Netherlands | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Santa SP. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Nowa Sol | Poland | Completed |
| Synexus Polska Sp z o o Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Neurosphera SP. Z O.O Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Completed |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Completed |
| Hospital da Luz Torres de Lisboa Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Unidade Local De Saude De Entre O Douro E Vouga E.P.E. Coordinator of this site? Confirm its status | Santa Maria Da Feira | Portugal | Completed |
| Unidade Local De Saude De Matosinhos E.P.E. Coordinator of this site? Confirm its status | Senhora Da Hora | Portugal | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.