Generalized EpilepsyPhase 2/3SHINENCT06425159
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
A Phase 2/3 study testing BHV-7000 in people with Generalized Epilepsy, run by Biohaven Therapeutics Ltd. at 109 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Generalized Epilepsy
- What is being tested?
- BHV-7000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 109 sitesin 14 countries
- Study dates
- 20 Jun 2024to 12 Mar 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
- Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks
- Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed).
- Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate 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 epilepsy treatments in total (e.g., each ASM is considered 1 treatment. Other epilepsy therapies including devices and diet therapy are allowed; together these other therapies count as 1 treatment).
- Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks.
Who cannot join
- History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired conscious for > 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
- History of repetitive/cluster GTC seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having repetitive/cluster GTC seizures count during the screening phase.
- Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator
Trial locations and contacts
109 sites in 14 countries.
109 sites in 14 countries
United States40 sites
Dent Neurosciences Research Center
Amherst, New York, 14226
Augusta University
Augusta, Georgia, 30912
OLOLRMC
Baton Rouge, Louisiana, 70808
Accel Research
Birmingham, Alabama, 35244
Consultants in Epilepsy & Neurology, PLLC (CEN)
Boise, Idaho, 83702
Boston Clinical Trials
Boston, Massachusetts, 02131
Nova Clinical Research, LLC
Bradenton, Florida, 34209
WR-ClinSearch
Chattanooga, Tennessee, 37421
Northwestern Medical Group, Department of Neurology
Chicago, Illinois, 60611
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243
ANESC Research
El Paso, Texas, 79912
Revive Research Institute, Inc.
Elgin, Illinois, 60123
NEREG
Hackensack, New Jersey, 07601
Boston Children's Health Physicians (BCHP)
Hawthorne, New York, 10532-1528
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
University of Florida (Jacksonville)
Jacksonville, Florida, 32209
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504
Somnos Clinical Research
Lincoln, Nebraska, 68510
Institute of Neurology and Neurosurgery
Livingston, New Jersey, 07039
Y&L Advance Health Care,Inc d/b/a Elite Clinical Research
Miami, Florida, 33144
Serenity Research Center
Miami, Florida, 33176
Intermountain Health
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Northwell Health Pediatric Neurology
New Hyde Park, New York, 11042
University Medical Center New Orleans
New Orleans, Louisiana, 70112
NYU Langone Health
New York, New York, 10016
Research Institute of Orlando
Orlando, Florida, 32806
Comprehensive Neurology Clinic
Orlando, Florida, 32825
Profound Research LLC
Pasadena, California, 91105
Barrow Neurological Institute
Phoenix, Arizona, 85013
ARENSIA Exploratory Medicine
Phoenix, Arizona, 85015
UPMC
Pittsburgh, Pennsylvania, 15213
Henrico Doctors' Neurology Associates, LLC
Richmond, Virginia, 23235
Knight Neurology
Rockledge, Florida, 32955
Road Runner Research, Ltd
San Antonio, Texas, 78249
Santos Research Center
Tampa, Florida, 33615
Montefiore Medical Center
The Bronx, New York, 10467
Center for Neurosciences
Tucson, Arizona, 85718
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010
Encore Medical Research of Weston LLC.
Weston, Florida, 33331
Italy14 sites
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Baggiovara, Modena, 41126
AUSL di Bologna - Ospedale Bellaria
Bologna, Emilia-Romagna, 40139
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
Catanzaro, Calabria, 88100
Ospedale Policlinico SS Annunziata - Chieti
Chieti, Abruzzo, 66013
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa, Liguria, 16147
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, 20132
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milan, Lombardy, 20142
AORN Antonio Cardarelli
Naples, Campania, 80131
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy, 27100
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Isernia, 86077
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Roma, 168
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, Lazio, 165
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, 37126
Germany11 sites
Vivantes - Humboldt Klinikum
Berlin, 13509
Krankenhaus Mara gGmbH
Bielefeld, North Rhine-Westphalia, 33617
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16
Frankfurt am Main, Hesse, 60528
Epilepsiezentrum Kork
Kehl, Baden-Wurttemberg, 77694
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
Marburg, Hesse, 35043
LMU Klinikum der Universität München - Campus Großhadern
München, Bavaria, 81377
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
Radeberg, Saxony, 01454
Epilepsie-Zentrum Bodensee
Ravensburg, 88214
Universitätsklinikum Ulm-Oberer Eselsberg 45
Ulm, Baden-Wurttemberg, 89081
Spain7 sites
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 8916
Hospital del Mar
Barcelona, 08003
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Regional Universitario de Malaga - Hospital General
Málaga, 29010
Centro de Neurologia Avanzada
Seville, 41013
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, 36312
Australia6 sites
St Vincents Hospital Melbourne - PPDS
Fitzroy, Victoria, 3065
Austin Hospital
Heidelberg, Victoria, 3084
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029
The Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Parkville, Victoria, 3050
Westmead Hospital
Westmead, New South Wales, 2145
France6 sites
Hospices Civils de Lyon - 59 Bd Pinel
Bron, Rhône, 69677
CHU Dijon Bourgogne
Dijon, Côte-d'Or, 21000
CHRU Lille
Lille, Nord, 59037
Hôpital Pontchaillou
Rennes, 35033
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, Bas-Rhin, 67000
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
Toulouse, Haute-Garonne, 31059
Poland6 sites
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546
Pratia MCM KrakÛw
Krakow, Lesser Poland Voivodeship, 30-727
Santa Familia PTG Lodz
Lódz, Lódzkie, 90-302
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702
Neurosphera SP. Z O.O Warsaw
Warsaw, 02-829
Portugal5 sites
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3000-075
Hospital da Luz Torres de Lisboa
Lisbon, 1600-209
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
Santa Maria da Feira, Aveiro District, 4520-211
ULS de Matosinhos, EPE - Hospital Pedro Hispano
Senhora da Hora, Porto District, 4464-513
United Kingdom5 sites
Neuroscience Research Centre
Fazakerley, L9 7LJ
University College London Hospitals
London, WC1N 3HR
Morriston Hospital
Morriston, SA6 6NL
The Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Salford Royal Hospital
Salford, M6 8HD
Belgium3 sites
UZ Antwerpen
Edegem, Antwerpen, 2650
UZ Gent
Ghent, Oost-Vlaanderen, 9000
CHU UCL Namur - Site Godinne
Yvoir, Namur, 5530
Austria2 sites
Christian Doppler-Klinik - Universitätsklinikum der PMU
Salzburg, A-5020
Medizinische Universität Wien
Vienna, 1090
Croatia2 sites
Clinical Hospital Dubrava
Zagreb, City of Zagreb, 10000
Clinical Hospital Sveti Duh
Zagreb, City of Zagreb, 10000
About this study
Official title: 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
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.
- Conditions
- Generalized Epilepsy
- Being tested
- BHV-7000, Placebo
- Keywords
- Idiopathic Generalized Epilepsy, Generalized, Epilepsy, tonic-clonic, generalized tonic-clonic, tonic, clonic, seizure, refractory epilepsy, generalized tonic-clonic alone, juvenile myoclonic epilepsy, juvenile absence epilepsy
- Medical subject headings
- Epilepsy, Generalized, Epilepsy, Idiopathic Generalized, Epilepsy, Seizures, Drug Resistant Epilepsy, Myoclonic Epilepsy, Juvenile, Epilepsy, Absence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-7000Drug
BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily
PlaceboDrug
Matching placebo taken once daily
| Study group | Role | What they receive |
|---|---|---|
| BHV-7000 75 mg | Active comparator | Not described Receives: Drug: BHV-7000 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period
To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures as measured by the time to the second day with a GTC seizure during the double-blind phase
Measured: Baseline to Week 24 of Double-Blind Treatment Period
Secondary outcomes (3)
Percentage of Participants with freedom of GTC seizures during DBT Phase
To compare the efficacy of BHV-7000 to placebo in terms of the proportion of subjects that are free of GTC seizures as measured by the proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan- Meier methods.
Measured: Baseline to Week 24 of Double-Blind Treatment Period
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 as measured by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs
Measured: Baseline to Week 24 of Double-Blind Treatment Period
Number of Participants With Clinically Significant Laboratory Abnormalities
To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with grade 3 and grade 4 laboratory abnormalities.
Measured: Baseline to Week 24 of Double-Blind Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start20 Jun 2024
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425159
- Sponsor's protocol ID
- BHV7000-304
- Other IDs
- 2023-508812-45-00, 2023
- Acronym
- SHINE
- Status last verified
- Mar 2026
- First submitted
- 17 May 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06425159
- Acronym / sponsor ID
- SHINE / BHV7000-304
- Conditions
- Generalized Epilepsy
- Keywords
- Idiopathic Generalized Epilepsy, Generalized, Epilepsy, tonic-clonic, generalized tonic-clonic, tonic, clonic, seizure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHV-7000 75 mg | Active comparator | Drug: BHV-7000 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
- Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate 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 epilepsy treatments in total (e.g., each ASM is considered 1 treatment. Other epilepsy therapies including devices and diet therapy are allowed; together these other therapies count as 1 treatment).
Key exclusion criteria (3 listed)
- History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired conscious for > 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
- History of repetitive/cluster GTC seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having repetitive/cluster GTC seizures count during the screening phase.
- Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHV-7000BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily | Drug | BHV-7000 75 mg |
| PlaceboMatching placebo taken once daily | Drug | Placebo |
Primary outcome
Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period
Time frame: Baseline to Week 24 of Double-Blind Treatment Period
To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures as measured by the time to the second day with a GTC seizure during the double-blind phase
3 secondary outcomes
Percentage of Participants with freedom of GTC seizures during DBT Phase
Time frame: Baseline to Week 24 of Double-Blind Treatment Period
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time frame: Baseline to Week 24 of Double-Blind Treatment Period
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Baseline to Week 24 of Double-Blind Treatment Period
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
109 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BHV-7000 in people with Generalized Epilepsy, run by Biohaven Therapeutics Ltd. at 109 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in United States, Italy, Germany, Spain, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period (time frame: Baseline to Week 24 of Double-Blind Treatment Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.