Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
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
25/11/2024

Titles & IDs
Public title
Long-term Safety and Tolerability of BHV-7000
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
Secondary ID [1] 0 0
2023-508813-18-00
Secondary ID [2] 0 0
BHV7000-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
Up to 52 weeks
Primary outcome [2] 0 0
Number of Subjects with Clinically Significant Laboratory Abnormalities
Timepoint [2] 0 0
Up to 52 weeks

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
660
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [4] 0 0
St Vincents Hospital Melbourne - PPDS - Fitzroy
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Vermont
Country [28] 0 0
United States of America
State/province [28] 0 0
Virginia
Country [29] 0 0
Argentina
State/province [29] 0 0
Buenos Aires
Country [30] 0 0
Argentina
State/province [30] 0 0
Ciudad Autónoma De BuenosAires
Country [31] 0 0
Argentina
State/province [31] 0 0
Tucumán
Country [32] 0 0
Argentina
State/province [32] 0 0
Ciudad Autónoma de Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Córdoba
Country [34] 0 0
Austria
State/province [34] 0 0
Oberösterreich
Country [35] 0 0
Austria
State/province [35] 0 0
Salzburg
Country [36] 0 0
Austria
State/province [36] 0 0
St. Pölten
Country [37] 0 0
Austria
State/province [37] 0 0
Wien
Country [38] 0 0
Belgium
State/province [38] 0 0
Antwerpen
Country [39] 0 0
Belgium
State/province [39] 0 0
Brussels
Country [40] 0 0
Belgium
State/province [40] 0 0
Namur
Country [41] 0 0
Belgium
State/province [41] 0 0
Oost-Vlaanderen
Country [42] 0 0
Chile
State/province [42] 0 0
Araucanía
Country [43] 0 0
Chile
State/province [43] 0 0
Región-MetropolitanadeSantiago
Country [44] 0 0
Chile
State/province [44] 0 0
Valparaíso
Country [45] 0 0
Croatia
State/province [45] 0 0
Grad Zagreb
Country [46] 0 0
Croatia
State/province [46] 0 0
Rijeka
Country [47] 0 0
Czechia
State/province [47] 0 0
Jihomoravský Kraj
Country [48] 0 0
Czechia
State/province [48] 0 0
Praha, Hlavní Mesto
Country [49] 0 0
Finland
State/province [49] 0 0
Pirkanmaa
Country [50] 0 0
Finland
State/province [50] 0 0
Pohjois-Savo
Country [51] 0 0
Finland
State/province [51] 0 0
Uusimaa
Country [52] 0 0
France
State/province [52] 0 0
Bas-Rhin
Country [53] 0 0
France
State/province [53] 0 0
Côte-d'Or
Country [54] 0 0
France
State/province [54] 0 0
Haute-Garonne
Country [55] 0 0
France
State/province [55] 0 0
Hérault
Country [56] 0 0
France
State/province [56] 0 0
Indre-et-Loire
Country [57] 0 0
France
State/province [57] 0 0
Meurthe-et-Moselle
Country [58] 0 0
France
State/province [58] 0 0
Nord
Country [59] 0 0
France
State/province [59] 0 0
Rhône
Country [60] 0 0
France
State/province [60] 0 0
Rennes
Country [61] 0 0
Germany
State/province [61] 0 0
Baden-Württemberg
Country [62] 0 0
Germany
State/province [62] 0 0
Bayern
Country [63] 0 0
Germany
State/province [63] 0 0
Brandenburg
Country [64] 0 0
Germany
State/province [64] 0 0
Hessen
Country [65] 0 0
Germany
State/province [65] 0 0
Niedersachsen
Country [66] 0 0
Germany
State/province [66] 0 0
Nordrhein-Westfalen
Country [67] 0 0
Germany
State/province [67] 0 0
Sachsen
Country [68] 0 0
Germany
State/province [68] 0 0
Berlin
Country [69] 0 0
Hungary
State/province [69] 0 0
Baranya
Country [70] 0 0
Hungary
State/province [70] 0 0
Hajdú-Bihar
Country [71] 0 0
Hungary
State/province [71] 0 0
Budapest
Country [72] 0 0
Italy
State/province [72] 0 0
Calabria
Country [73] 0 0
Italy
State/province [73] 0 0
Campania
Country [74] 0 0
Italy
State/province [74] 0 0
Emilia-Romagna
Country [75] 0 0
Italy
State/province [75] 0 0
Lazio
Country [76] 0 0
Italy
State/province [76] 0 0
Liguria
Country [77] 0 0
Italy
State/province [77] 0 0
Lombardia
Country [78] 0 0
Italy
State/province [78] 0 0
Marche
Country [79] 0 0
Italy
State/province [79] 0 0
Modena
Country [80] 0 0
Italy
State/province [80] 0 0
Molise
Country [81] 0 0
Italy
State/province [81] 0 0
Toscana
Country [82] 0 0
Italy
State/province [82] 0 0
Roma
Country [83] 0 0
Italy
State/province [83] 0 0
Rome
Country [84] 0 0
Italy
State/province [84] 0 0
Verona
Country [85] 0 0
Netherlands
State/province [85] 0 0
Noord-Brabant
Country [86] 0 0
Netherlands
State/province [86] 0 0
Noord-Holland
Country [87] 0 0
Netherlands
State/province [87] 0 0
Overijssel
Country [88] 0 0
Poland
State/province [88] 0 0
Dolnoslaskie
Country [89] 0 0
Poland
State/province [89] 0 0
Lubelskie
Country [90] 0 0
Poland
State/province [90] 0 0
Lubuskie
Country [91] 0 0
Poland
State/province [91] 0 0
Lódzkie
Country [92] 0 0
Poland
State/province [92] 0 0
Mazowieckie
Country [93] 0 0
Poland
State/province [93] 0 0
Pomorskie
Country [94] 0 0
Poland
State/province [94] 0 0
Wielkopolskie
Country [95] 0 0
Poland
State/province [95] 0 0
Gdansk
Country [96] 0 0
Poland
State/province [96] 0 0
Kraków
Country [97] 0 0
Portugal
State/province [97] 0 0
Aveiro
Country [98] 0 0
Portugal
State/province [98] 0 0
Porto
Country [99] 0 0
Portugal
State/province [99] 0 0
Braga
Country [100] 0 0
Portugal
State/province [100] 0 0
Coimbra
Country [101] 0 0
Portugal
State/province [101] 0 0
Lisboa
Country [102] 0 0
Slovenia
State/province [102] 0 0
Maribor
Country [103] 0 0
Spain
State/province [103] 0 0
Barcelona
Country [104] 0 0
Spain
State/province [104] 0 0
Navarra
Country [105] 0 0
Spain
State/province [105] 0 0
Pontevedra
Country [106] 0 0
Spain
State/province [106] 0 0
Granada
Country [107] 0 0
Spain
State/province [107] 0 0
Madrid
Country [108] 0 0
Spain
State/province [108] 0 0
Málaga
Country [109] 0 0
Spain
State/province [109] 0 0
Sevilla
Country [110] 0 0
Spain
State/province [110] 0 0
Valencia
Country [111] 0 0
Spain
State/province [111] 0 0
Valladolid
Country [112] 0 0
Switzerland
State/province [112] 0 0
Zürich (de)
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Glamorgan
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Glasgow City
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Manchester
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Merseyside
Country [117] 0 0
United Kingdom
State/province [117] 0 0
South Glamorgan
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biohaven Therapeutics Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
Trial website
https://clinicaltrials.gov/study/NCT06443463
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06443463