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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06425159




Registration number
NCT06425159
Ethics application status
Date submitted
17/05/2024
Date registered
22/05/2024
Date last updated
20/12/2024

Titles & IDs
Public title
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
Scientific title
A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension
Secondary ID [1] 0 0
2023-508812-45-00
Secondary ID [2] 0 0
BHV7000-304
Universal Trial Number (UTN)
Trial acronym
SHINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalized Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BHV-7000
Treatment: Drugs - Placebo

Active comparator: BHV-7000 75 mg -

Placebo comparator: Placebo -


Treatment: Drugs: BHV-7000
BHV-7000 75mg. 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
Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period
Timepoint [1] 0 0
Baseline to Week 24 of Double-Blind Treatment Period
Secondary outcome [1] 0 0
Percentage of Participants with freedom of GTC seizures during DBT Phase
Timepoint [1] 0 0
Baseline to Week 24 of Double-Blind Treatment Period
Secondary outcome [2] 0 0
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Timepoint [2] 0 0
Baseline to Week 24 of Double-Blind Treatment Period
Secondary outcome [3] 0 0
Number of Participants With Clinically Significant Laboratory Abnormalities
Timepoint [3] 0 0
Baseline to Week 24 of Double-Blind Treatment Period

Eligibility
Key inclusion criteria
* Male and Female participants 18 to 75 years of age at time of consent.
* Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.

1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks
2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed).
* Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
* Ability of subject or caregiver to keep accurate seizure diaries
* Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.).
* Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having an unknown GTC seizure count during the screening phase.
* Any condition that would interfere with 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
20/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
242
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [3] 0 0
St Vincents Hospital Melbourne - PPDS - Fitzroy
Recruitment hospital [4] 0 0
Austin Hospital - 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
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
State/province [5] 0 0
District of Columbia
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United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
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United States of America
State/province [8] 0 0
Idaho
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United States of America
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Illinois
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United States of America
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Nebraska
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New Jersey
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New York
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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Texas
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United States of America
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Utah
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United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
Austria
State/province [23] 0 0
Wien
Country [24] 0 0
Germany
State/province [24] 0 0
Baden-Württemberg
Country [25] 0 0
Germany
State/province [25] 0 0
Nordrhein-Westfalen
Country [26] 0 0
Italy
State/province [26] 0 0
Isernia
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Italy
State/province [27] 0 0
Liguria
Country [28] 0 0
Italy
State/province [28] 0 0
Verona
Country [29] 0 0
Netherlands
State/province [29] 0 0
Noord-Brabant
Country [30] 0 0
Poland
State/province [30] 0 0
Lubuskie
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Poland
State/province [31] 0 0
Malopolskie
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Poland
State/province [32] 0 0
Pomorskie
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Poland
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Wielkopolskie
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Poland
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Warszawa
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Portugal
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Porto
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Portugal
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Braga
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Spain
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Pontevedra
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Spain
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Barcelona
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Spain
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Málaga
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Spain
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Sevilla
Country [41] 0 0
Spain
State/province [41] 0 0
Valladolid

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
Chief Medical Officer
Address 0 0
Country 0 0
Phone 0 0
203-404-0410
Fax 0 0
Email 0 0
clinicaltrials@biohavenpharma.com
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/NCT06425159