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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06309966




Registration number
NCT06309966
Ethics application status
Date submitted
8/03/2024
Date registered
13/03/2024
Date last updated
7/11/2024

Titles & IDs
Public title
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Scientific title
A Phase 2/3 Multicenter, Randomization, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
Secondary ID [1] 0 0
2023-508811-21
Secondary ID [2] 0 0
BHV7000-303
Universal Trial Number (UTN)
Trial acronym
RISE 3
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
Treatment: Drugs - Placebo

Experimental: BHV-7000 50 mg -

Experimental: BHV-7000 75 mg -

Placebo comparator: Placebo -


Treatment: Drugs: BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily

Treatment: Drugs: BHV-7000
BHV-7000 75 mg. Participants will take blinded investigational product (IP) once daily

Treatment: Drugs: Placebo
Matching placebo taken once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in 28-day average seizure frequency
Timepoint [1] 0 0
Baseline, Week 8 to Week 16
Secondary outcome [1] 0 0
Percentage of Participants with at at least 50% reduction in seizure frequency per month
Timepoint [1] 0 0
Baseline, Week 8 to Week 16
Secondary outcome [2] 0 0
Change from Baseline in 28-day average seizure frequency during first month of treatment
Timepoint [2] 0 0
Baseline, Week 8 to Week 12
Secondary outcome [3] 0 0
Percentage of Participants with at at least 75% reduction in seizure frequency per month
Timepoint [3] 0 0
Baseline, Week 8 to Week 16
Secondary outcome [4] 0 0
Change from baseline in 7-day adjusted seizure frequency during first week of treatment
Timepoint [4] 0 0
Baseline, Week 8 to Week 9
Secondary outcome [5] 0 0
Change from baseline in Patient Global Impression of Change (PGI-C)
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [6] 0 0
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Timepoint [6] 0 0
Week 8 to Week 16
Secondary outcome [7] 0 0
Number of Participants With Clinically Significant Laboratory Abnormalities
Timepoint [7] 0 0
Week 8 to Week 16
Secondary outcome [8] 0 0
Percentage of Participants with seizure freedom during DB Phase
Timepoint [8] 0 0
Week 8 to Week 16

Eligibility
Key inclusion criteria
Key

1. Male and Female participants 18 to 75 years of age at time of consent.
2. 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.

a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures with clinically observable signs and/or symptoms iii. Focal to bilateral tonic-clonic seizures
3. 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.
4. Ability to keep accurate seizure diaries
5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.)

Key
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.
2. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
3. Resection neurosurgery for seizures <4 months prior to the screening visit.
4. Radiosurgery performed <2 years prior to the screening visit.
5. 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.
6. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
13/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
390
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
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California
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Connecticut
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District of Columbia
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Florida
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United States of America
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Louisiana
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Denmark
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Fyn
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Finland
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Pirkanmaa
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Finland
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Pohjois-Savo
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Finland
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Uusimaa
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Berlin
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Italy
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Calabria
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Marche
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Italy
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Modena
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Italy
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Molise
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Italy
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Toscana
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Roma
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Rome
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Verona
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Portugal
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Aveiro
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Portugal
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Porto
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Braga
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Portugal
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Coimbra
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Portugal
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Lisboa
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Spain
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Barcelona
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Navarra
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Pontevedra
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Granada
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Madrid
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Málaga
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Sevilla
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Valencia
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Spain
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Valladolid
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United Kingdom
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Glamorgan
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United Kingdom
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Glasgow City
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United Kingdom
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Manchester
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United Kingdom
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Merseyside
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United Kingdom
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South Glamorgan
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United Kingdom
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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
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Trial website
https://clinicaltrials.gov/study/NCT06309966
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
Chief Medical Officer
Address 0 0
Country 0 0
Phone 0 0
203-404-0410
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06309966