Focal EpilepsyPhase 2/3RISE 2NCT06132893
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
A Phase 2/3 study testing BHV-7000 in people with Focal Epilepsy, run by Biohaven Therapeutics Ltd. at 104 sites in 12 countries.
Trial summary
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- BHV-7000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 104 sitesin 12 countries
- Study dates
- 14 Mar 2024to Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
- Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures
- Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
- Ability to keep accurate seizure diaries
- Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total
Who cannot join
- History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired consciousness 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 seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
- Resection neurosurgery for seizures <4 months prior to the screening visit.
- Radiosurgery performed <2 years prior to the screening visit.
- Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.
- Any condition 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
Trial locations and contacts
104 sites in 12 countries.
104 sites in 12 countries
United States49 sites
Dent Neurosciences Research Center
Amherst, New York, 14226
Augusta University
Augusta, Georgia, 30912
University of Colorado Anschultz Medical Campus
Aurora, Colorado, 80045
MAESC
Bethesda, Maryland, 20817
EZR Research LLC
Boca Raton, Florida, 33486
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702
Nova Clinical Research, LLC
Bradenton, Florida, 34209
NeuroScience Research Center
Canton, Ohio, 44718
University of Virginia
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45267
OSU
Columbus, Ohio, 43214
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243
Revive Research Institute, Inc.
Elgin, Illinois, 60123
Tarrant Neurology Consultants
Fort Worth, Texas, 76104
NEREG
Hackensack, New Jersey, 07601
BCHP
Hawthorne, New York, 10532
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
University of Florida (Jacksonville)
Jacksonville, Florida, 32209
University of California San Diego
La Jolla, California, 92041
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504
Clinical Trials, Inc.
Little Rock, Arkansas, 72205
Inst of Neurology
Livingston, New Jersey, 07039
University of California, Los Angeles
Los Angeles, California, 90095
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale School of Medicine - Yale-New Haven Hospital
New Haven, Connecticut, 06519
Northwell Health
New York, New York, 10021
Stanford Health Care
Palo Alto, California, 94304
Profound Research LLC
Pasadena, California, 91105
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
UPMC
Pittsburgh, Pennsylvania, 15213
Medsol Clinical Research Center
Port Charlotte, Florida, 33952
Henrico Doctors Neurology Associates, LLC
Richmond, Virginia, 23235
Carilion Clinic
Roanoke, Virginia, 24011
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota, 55113
University of Utah
Salt Lake City, Utah, 84132
UT Health San Antonio
San Antonio, Texas, 78229
Road Runner Research, Ltd
San Antonio, Texas, 78249
Javara
Silver Spring, Maryland, 20901
Washington University School of Medicine
St Louis, Missouri, 63110
Stony Brook Medicine
Stony Brook, New York, 11794
Santos Research Center
Tampa, Florida, 33615
Center for Neurosciences
Tucson, Arizona, 85718
Encore Medical Research of Weston LLC.
Weston, Florida, 33331
Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Five Towns Neuroscience Research
Woodmere, New York, 11598
Poland13 sites
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546
Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
Gdansk, 80-803
Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
Katowice, 40-594
Pratia MCM Kraków
Krakow, 30-727
LANDA Specjalistyczne Gabinety Lekarskie
Krakow, 31-156
Santa Familia PTG Lodz
Lodz, Lódzkie, 90-302
Clinical Best Solutions - Lublin
Lublin, Lublin Voivodeship, 20-078
Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, Lubusz Voivodeship, 67-100
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702
NZOZ IGNIS dr med. Alicja Lobinska
Świdnik, Lublin Voivodeship, 21-040
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship, 02-172
Neurosphera SP. Z O.O
Warsaw, Masovian Voivodeship, 02-829
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, 02-957
Argentina9 sites
Hospital General de Agudos Dr. José María Ramos Mejia
Balvanera, Ciudad Autónoma de BuenosAires, C1221ADC
Hospital Británico de Buenos Aires
Buenos Aires, Ciudad Autónoma de BuenosAires, C1437JCH
Sanatorio de la Trinidad - Mitre
Buenos Aires, C1039AAO
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
Buenos Aires, C1428AQK
STAT Research S.A.
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1013AAB
Instituto Privado Kremer
Córdoba, X5004AOA
Conci Carpinella - Santa Rosa N° 748
Córdoba, X5008HHW
Investigaciones Sanatorio Del Sur
San Miguel de Tucumán, Tucumán Province, T4000AXL
France9 sites
CHU Dijon Bourgogne
Dijon, Côte-d'Or, 21000
CHU de Lille - Hopital Claude Huriez
Lille, Nord, 59037
Hospices Civils de Lyon - 59 Bd Pinel
Lyon, Rhône, 69003
CHU de Montpellier- Hôpital Gui De Chauliac
Montpellier, Hérault, 34295
CHRU Nancy
Nancy, Meurthe-et-Moselle, 54000
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
CHRU de Tours - Hôpital Bretonneau
Tours, Indre-et-Loire, 37000
Belgium5 sites
Hôpital Erasme
Anderlecht, Brussels Capital, 1070
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200
UZ Antwerpen
Edegem, Antwerpen, 2650
UZ Gent
Ghent, Oost-Vlaanderen, 9000
CHU UCL Namur - Site Godinne
Yvoir, Namur, 5530
Chile5 sites
Hospital Padre Hurtado
Santiago, Región-MetropolitanadeSantiago, 8260094
BIOCINETIC Ltda
Santiago, Región-MetropolitanadeSantiago, 8320000
Centro de Investigacion Clinica UC
Santiago, Región-MetropolitanadeSantiago, 8320000
Centro de especialidades médicas Vanguardia
Temuco, Araucania, 4780000
Instituto Neurologico Thalamus
Viña del Mar, Valparaiso, 2520021
Austria4 sites
Kepler Universitätsklinikum Linz - Med Campus III
Linz, Upper Austria, 4020
Christian Doppler-Klinik - Universitätsklinikum der PMU
Salzburg, 5020
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, 1090
Hungary4 sites
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106
SE INK Juhasz Pal Epilepszia Központ
Budapest, 1145
Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
Debrecen, Hajdú-Bihar, 4031
Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
Pécs, Baranya, 7623
Netherlands3 sites
Stichting Epilepsie Instellingen Nederland - Heemstede
Heemstede, North Holland, 2103 SW
Kempenhaeghe - PPDS
Heeze, North Brabant, 5591 VE
Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
Zwolle, Overijssel, 8025 BV
Czechia1 site
Fakultni nemocnice u sv. Anny v Brne
Brno, South Moravian, 602 00
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 in Subjects With Refractory Focal Onset Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Read the detailed description
This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.
- Conditions
- Focal Epilepsy
- Being tested
- BHV-7000, Placebo
- Keywords
- Focal Epilepsy, Epilepsy, Seizure, Refractory Epilepsy, Partial Epilepsy
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Seizures, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-7000Drug
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
BHV-7000Drug
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
PlaceboDrug
Matching placebo taken once daily
BHV-7000Drug
BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
PlaceboDrug
Matching placebo taken once daily
| Study group | Role | What they receive |
|---|---|---|
| BHV-7000 25 mg Part A | Experimental | Not described Receives: Drug: BHV-7000 |
| BHV-7000 50 mg Part A | Experimental | Not described Receives: Drug: BHV-7000 |
| Placebo Part A | Placebo comparator | Not described Receives: Drug: Placebo |
| BHV-7000 75 mg Part B | Experimental | Not described Receives: Drug: BHV-7000 |
| Placebo Part B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part B: Change from Baseline in 28-day average seizure frequency
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.
Measured: Baseline, Week 8 to Week 20 of Part B
Part A: 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. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
Measured: Week 8 to Week 20 of Part A
Part A: Number of Participants With Clinically Significant Laboratory Abnormalities
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.
Measured: Week 8 to Week 20 of Part A
Secondary outcomes (8)
Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month
To compare the efficacy of 2 dose strengths of BHV-7000 to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 12 week double-blind phase to the observation phase.
Measured: Baseline, Week 8 to Week 20 of Part B
Part B: Change from Baseline in 28-day average seizure frequency during first month of treatment
To compare the efficacy of BHV-7000 to placebo during the first month of treatment. This objective will be measured by the change in log-transformed 28-day adjusted seizure frequency from observation phase over the first month of the double blind phase.
Measured: Baseline, Week 8 to Week 12 of Part B
Part B: Percentage of Participants with at at least 75% reduction in seizure frequency per month
To compare the efficacy of BHV-7000 to placebo as measured by the proportion of subjects that have at least a 75% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the double-blind phase compared to the observation phase.
Measured: Baseline, Week 8 to Week 20 of Part B
Part B: Percentage of Participants with seizure freedom during DB Phase
To compare the efficacy of BHV-7000 to placebo on seizure freedom (100% seizure reduction during the DB phase). This objective will be measured by proportion of subjects that are seizure free during the double-blind phase.
Measured: Week 8 to Week 20 of Part B
Part B: Change from baseline in 7-day adjusted seizure frequency during first week of treatment
To compare the efficacy of BHV-7000 to placebo during the first week of treatment. This objective will be measured by the change in log-transformed 7-day adjusted seizure frequency from observation phase over the first week of the double-blind phase.
Measured: Baseline, Week 8 to Week 9 of Part B
Part B: Change from baseline in Patient Global Impression of Change (PGI-C)
To compare the efficacy of BHV-7000 to placebo on the patient global impression of change (PGI-C). This objective will be measured by proportion of subjects at week 12 of double-blind treatment phase with a PGI-C response of "minimally improved", "much improved" or "very much improved". This scale is a 7-point Likert scale with response options of:
(1) "very much improved" , (2) "much improved", (3) "minimally improved", (4) "no change", (5) "minimally worse", (6) "much worse", (7) and "very much worse"
Measured: Baseline, Week 20 of Part B
Part B: 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. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
Measured: Week 8 to Week 20 of Part B
Part B: Number of Participants With Clinically Significant Laboratory Abnormalities
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.
Measured: Week 8 to Week 20 of Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start14 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132893
- Sponsor's protocol ID
- BHV7000-302
- Other IDs
- 2023-508539-30, 2023
- Acronym
- RISE 2
- Status last verified
- Sep 2026
- First submitted
- 10 Nov 2023
- Last updated
- 30 Sep 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 30 Sep 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 in Subjects With Refractory Focal Onset Epilepsy
- ClinicalTrials.gov ID
- NCT06132893
- Acronym / sponsor ID
- RISE 2 / BHV7000-302
- Conditions
- Focal Epilepsy
- Keywords
- Focal Epilepsy, Epilepsy, Seizure, Refractory Epilepsy, Partial Epilepsy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Nov 2023 (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 refractory focal epilepsy.
Detailed description
This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BHV-7000 25 mg Part A | Experimental | Drug: BHV-7000 |
| BHV-7000 50 mg Part A | Experimental | Drug: BHV-7000 |
| Placebo Part A | Placebo comparator | Drug: Placebo |
| BHV-7000 75 mg Part B | Experimental | Drug: BHV-7000 |
| Placebo Part B | 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 (6 listed)
- Male and Female participants 18 to 75 years of age at time of consent.
- Diagnosis of Focal Onset Epilepsy at least 1 year prior to 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 anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
- Ability to keep accurate seizure diaries
- Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total
Key exclusion criteria (6 listed)
- History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired consciousness 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 seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
- Resection neurosurgery for seizures <4 months prior to the screening visit.
- Radiosurgery performed <2 years prior to the screening visit.
- Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.
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 25 mg. Participants will take blinded investigational product (IP) once daily | Drug | BHV-7000 25 mg Part A |
| BHV-7000BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily | Drug | BHV-7000 50 mg Part A |
| PlaceboMatching placebo taken once daily | Drug | Placebo Part A |
| BHV-7000BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily | Drug | BHV-7000 75 mg Part B |
| PlaceboMatching placebo taken once daily | Drug | Placebo Part B |
Primary outcome
Part B: Change from Baseline in 28-day average seizure frequency
Time frame: Baseline, Week 8 to Week 20 of Part B
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.
Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time frame: Week 8 to Week 20 of Part A
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
Part A: Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Week 8 to Week 20 of Part A
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.
8 secondary outcomes
Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month
Time frame: Baseline, Week 8 to Week 20 of Part B
Part B: Change from Baseline in 28-day average seizure frequency during first month of treatment
Time frame: Baseline, Week 8 to Week 12 of Part B
Part B: Percentage of Participants with at at least 75% reduction in seizure frequency per month
Time frame: Baseline, Week 8 to Week 20 of Part B
Part B: Percentage of Participants with seizure freedom during DB Phase
Time frame: Week 8 to Week 20 of Part B
Part B: Change from baseline in 7-day adjusted seizure frequency during first week of treatment
Time frame: Baseline, Week 8 to Week 9 of Part B
Part B: Change from baseline in Patient Global Impression of Change (PGI-C)
Time frame: Baseline, Week 20 of Part B
Part B: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time frame: Week 8 to Week 20 of Part B
Part B: Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Week 8 to Week 20 of Part B
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
104 sites in 12 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 Focal Epilepsy, run by Biohaven Therapeutics Ltd. at 104 sites in 12 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Poland, Argentina, France, Belgium and 7 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?
This study is still under way. Results are not available in the source record yet.
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?
Part B: Change from Baseline in 28-day average seizure frequency (time frame: Baseline, Week 8 to Week 20 of Part B). The study lists 3 primary outcomes in all. 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 30 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.