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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
3/10/2024

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,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
St Vincents Hospital Melbourne - PPDS - Fitzroy
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 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
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
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Arizona
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Arkansas
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District of Columbia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biohaven Therapeutics Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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