Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06443463
Registration number
NCT06443463
Ethics application status
Date submitted
30/05/2024
Date registered
5/06/2024
Date last updated
11/05/2025
Titles & IDs
Public title
Long-term Safety and Tolerability of BHV-7000
Query!
Scientific title
A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
Query!
Secondary ID [1]
0
0
2023-508813-18-00
Query!
Secondary ID [2]
0
0
BHV7000-201
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Focal Epilepsy
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Epilepsy
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - BHV-7000
Treatment: Drugs - BHV-7000
Experimental: BHV-7000 50 mg -
Experimental: BHV-7000 75 mg -
Treatment: Drugs: BHV-7000
BHV-7000 50 mg. Participants will take open-label investigational product (IP) once daily
Treatment: Drugs: BHV-7000
BHV-7000 75 mg. Participants will take open-label investigational product (IP) once daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to 52 weeks
Query!
Primary outcome [2]
0
0
Number of Subjects with Clinically Significant Laboratory Abnormalities
Query!
Assessment method [2]
0
0
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
Query!
Timepoint [2]
0
0
Up to 52 weeks
Query!
Eligibility
Key inclusion criteria
Key
* Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303.
* (FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, 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.
* Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/07/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/01/2027
Query!
Actual
Query!
Sample size
Target
660
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Prince of Wales Hospital - Randwick
Query!
Recruitment hospital [3]
0
0
Royal Brisbane & Women's Hospital - Herston
Query!
Recruitment hospital [4]
0
0
St Vincents Hospital Melbourne - PPDS - Fitzroy
Query!
Recruitment hospital [5]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [6]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [7]
0
0
Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [5]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [6]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [7]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Hawaii
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Idaho
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Illinois
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Iowa
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kentucky
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Louisiana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Maryland
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Massachusetts
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Michigan
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Minnesota
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Missouri
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Nebraska
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New Jersey
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New York
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
North Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Ohio
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Oregon
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Pennsylvania
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
South Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Tennessee
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Texas
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Utah
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Vermont
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Virginia
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Buenos Aires
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Ciudad Autónoma De BuenosAires
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Tucumán
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Ciudad Autónoma de Buenos Aires
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Córdoba
Query!
Country [38]
0
0
Austria
Query!
State/province [38]
0
0
Oberösterreich
Query!
Country [39]
0
0
Austria
Query!
State/province [39]
0
0
Salzburg
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
St. Pölten
Query!
Country [41]
0
0
Austria
Query!
State/province [41]
0
0
Wien
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Antwerpen
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Brussels
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Namur
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Oost-Vlaanderen
Query!
Country [46]
0
0
Chile
Query!
State/province [46]
0
0
Araucanía
Query!
Country [47]
0
0
Chile
Query!
State/province [47]
0
0
Región-MetropolitanadeSantiago
Query!
Country [48]
0
0
Chile
Query!
State/province [48]
0
0
Valparaíso
Query!
Country [49]
0
0
Croatia
Query!
State/province [49]
0
0
Grad Zagreb
Query!
Country [50]
0
0
Croatia
Query!
State/province [50]
0
0
Rijeka
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Jihomoravský Kraj
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Praha, Hlavní Mesto
Query!
Country [53]
0
0
Denmark
Query!
State/province [53]
0
0
Fyn
Query!
Country [54]
0
0
Finland
Query!
State/province [54]
0
0
Pirkanmaa
Query!
Country [55]
0
0
Finland
Query!
State/province [55]
0
0
Pohjois-Savo
Query!
Country [56]
0
0
Finland
Query!
State/province [56]
0
0
Uusimaa
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Bas-Rhin
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Côte-d'Or
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Haute-Garonne
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Hérault
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Indre-et-Loire
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Meurthe-et-Moselle
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Nord
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Rhône
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Rennes
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Baden-Württemberg
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Bayern
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Brandenburg
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Hessen
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Niedersachsen
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Nordrhein-Westfalen
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Sachsen
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Berlin
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Ravensburg
Query!
Country [75]
0
0
Hungary
Query!
State/province [75]
0
0
Baranya
Query!
Country [76]
0
0
Hungary
Query!
State/province [76]
0
0
Hajdú-Bihar
Query!
Country [77]
0
0
Hungary
Query!
State/province [77]
0
0
Budapest
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Abruzzo
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Calabria
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Campania
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Emilia-Romagna
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Lazio
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Liguria
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Lombardia
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Marche
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Modena
Query!
Country [87]
0
0
Italy
Query!
State/province [87]
0
0
Molise
Query!
Country [88]
0
0
Italy
Query!
State/province [88]
0
0
Toscana
Query!
Country [89]
0
0
Italy
Query!
State/province [89]
0
0
Roma
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
Rome
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Verona
Query!
Country [92]
0
0
Netherlands
Query!
State/province [92]
0
0
Noord-Brabant
Query!
Country [93]
0
0
Netherlands
Query!
State/province [93]
0
0
Noord-Holland
Query!
Country [94]
0
0
Netherlands
Query!
State/province [94]
0
0
Overijssel
Query!
Country [95]
0
0
Poland
Query!
State/province [95]
0
0
Dolnoslaskie
Query!
Country [96]
0
0
Poland
Query!
State/province [96]
0
0
Lubelskie
Query!
Country [97]
0
0
Poland
Query!
State/province [97]
0
0
Lubuskie
Query!
Country [98]
0
0
Poland
Query!
State/province [98]
0
0
Lódzkie
Query!
Country [99]
0
0
Poland
Query!
State/province [99]
0
0
Mazowieckie
Query!
Country [100]
0
0
Poland
Query!
State/province [100]
0
0
Pomorskie
Query!
Country [101]
0
0
Poland
Query!
State/province [101]
0
0
Wielkopolskie
Query!
Country [102]
0
0
Poland
Query!
State/province [102]
0
0
Gdansk
Query!
Country [103]
0
0
Poland
Query!
State/province [103]
0
0
Katowice
Query!
Country [104]
0
0
Poland
Query!
State/province [104]
0
0
Kraków
Query!
Country [105]
0
0
Portugal
Query!
State/province [105]
0
0
Aveiro
Query!
Country [106]
0
0
Portugal
Query!
State/province [106]
0
0
Porto
Query!
Country [107]
0
0
Portugal
Query!
State/province [107]
0
0
Braga
Query!
Country [108]
0
0
Portugal
Query!
State/province [108]
0
0
Coimbra
Query!
Country [109]
0
0
Portugal
Query!
State/province [109]
0
0
Lisboa
Query!
Country [110]
0
0
Slovenia
Query!
State/province [110]
0
0
Maribor
Query!
Country [111]
0
0
South Africa
Query!
State/province [111]
0
0
Western Cape
Query!
Country [112]
0
0
Spain
Query!
State/province [112]
0
0
Barcelona
Query!
Country [113]
0
0
Spain
Query!
State/province [113]
0
0
Navarra
Query!
Country [114]
0
0
Spain
Query!
State/province [114]
0
0
Pontevedra
Query!
Country [115]
0
0
Spain
Query!
State/province [115]
0
0
Granada
Query!
Country [116]
0
0
Spain
Query!
State/province [116]
0
0
Madrid
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
Málaga
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Sevilla
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
Valencia
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Valladolid
Query!
Country [121]
0
0
Switzerland
Query!
State/province [121]
0
0
Zürich (de)
Query!
Country [122]
0
0
United Kingdom
Query!
State/province [122]
0
0
Glamorgan
Query!
Country [123]
0
0
United Kingdom
Query!
State/province [123]
0
0
Glasgow City
Query!
Country [124]
0
0
United Kingdom
Query!
State/province [124]
0
0
Manchester
Query!
Country [125]
0
0
United Kingdom
Query!
State/province [125]
0
0
Merseyside
Query!
Country [126]
0
0
United Kingdom
Query!
State/province [126]
0
0
Middlesex
Query!
Country [127]
0
0
United Kingdom
Query!
State/province [127]
0
0
Oxfordshire
Query!
Country [128]
0
0
United Kingdom
Query!
State/province [128]
0
0
South Glamorgan
Query!
Country [129]
0
0
United Kingdom
Query!
State/province [129]
0
0
Newcastle Upon Tyne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Biohaven Therapeutics Ltd.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
Query!
Trial website
https://clinicaltrials.gov/study/NCT06443463
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06443463
Download to PDF