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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
28/08/2024
Titles & IDs
Public title
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
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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
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Secondary ID [1]
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2023-808811-21
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Secondary ID [2]
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BHV7000-303
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Universal Trial Number (UTN)
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Trial acronym
RISE 3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Focal Epilepsy
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Condition category
Condition code
Neurological
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Epilepsy
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from Baseline in 28-day average seizure frequency
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Assessment method [1]
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To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from baseline in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 8-week double-blind treatment phase.
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Timepoint [1]
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Baseline, Week 8 to Week 16
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Secondary outcome [1]
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Percentage of Participants with at at least 50% reduction in seizure frequency per month
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Assessment method [1]
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To compare the efficacy of 2 dose strengths of BHV-7000 to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 8 week double-blind phase to the observation phase.
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Timepoint [1]
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Baseline, Week 8 to Week 16
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Secondary outcome [2]
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Change from Baseline in 28-day average seizure frequency during first month of treatment
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Assessment method [2]
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To compare the efficacy of BHV-7000 to placebo during the first month of treatment. This objective will be measured by the change in log-transformed 28-day adjusted seizure frequency from observation phase over the first month of the double blind phase.
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Timepoint [2]
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Baseline, Week 8 to Week 12
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Secondary outcome [3]
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Percentage of Participants with at at least 75% reduction in seizure frequency per month
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Assessment method [3]
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To compare the efficacy of BHV-7000 to placebo as measured by the proportion of subjects that have at least a 75% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the double-blind phase compared to the observation phase.
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Timepoint [3]
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Baseline, Week 8 to Week 16
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Secondary outcome [4]
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Change from baseline in 7-day adjusted seizure frequency during first week of treatment
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Assessment method [4]
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To compare the efficacy of BHV-7000 to placebo during the first week of treatment. This objective will be measured by the change in log-transformed 7-day adjusted seziure frequency from observation phase over the first week of the double-blind phase.
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Timepoint [4]
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Baseline, Week 8 to Week 9
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Secondary outcome [5]
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Change from baseline in Patient Global Impression of Change (PGI-C)
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Assessment method [5]
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To compare the efficacy of BHV-7000 to placebo on the patient global impression of change (PGI-C). This objective will be measured by proportion of subjects at week 16 with a PGI-C response of "minimally improved", "much improved" or "very much improved". This scale is a 7-point Likert scale with response options of:
(1) "very much improved" , (2) "much improved", (3) "minimally improved", (4) "no change", (5) "minimally worse", (6) "much worse", (7) and "very much worse"
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Timepoint [5]
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Baseline, Week 16
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Secondary outcome [6]
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Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
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Assessment method [6]
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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.
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Timepoint [6]
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Week 8 to Week 16
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Secondary outcome [7]
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Number of Participants With Clinically Significant Laboratory Abnormalities
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Assessment method [7]
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To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.
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Timepoint [7]
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Week 8 to Week 16
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Secondary outcome [8]
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Percentage of Participants with seizure freedom during DB Phase
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Assessment method [8]
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To compare the efficacy of BHV-7000 to placebo on seizure freedom (100% seizure reduction during the DBP phase). This objective will be measured by proportion of subjects that are seizure free during the double-blind phase.
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Timepoint [8]
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Week 8 to Week 16
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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.)
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Minimum age
18
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/05/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2025
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Actual
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Sample size
Target
390
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [3]
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St Vincents Hospital Melbourne - PPDS - Fitzroy
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Recruitment hospital [4]
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Austin Health - Heidelberg
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Recruitment hospital [5]
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The Alfred Hospital - Melbourne
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Recruitment hospital [6]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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3065 - Fitzroy
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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Arizona
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Louisiana
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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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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Spain
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Barcelona
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Spain
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Navarra
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Spain
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Pontevedra
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Spain
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Granada
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Sevilla
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Spain
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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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Glasgow City
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Manchester
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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
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Biohaven Therapeutics Ltd.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
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Trial website
https://clinicaltrials.gov/study/NCT06309966
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Chief Medical Officer
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Phone
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203-404-0410
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Email
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[email protected]
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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/NCT06309966
Download to PDF