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By invitation only Phase 2 NCT06443463

Long-term Safety and Tolerability of BHV-7000

Phase 2 – studying effectiveness and dosage
Conditions: Focal Epilepsy

Sponsor: Biohaven Therapeutics Ltd.

trial.available_in: БГ
Overview
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
Who can participate
Key Inclusion Criteria: * 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 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
Locations 23
Argentina (1)
STAT Research S.A.
Ciudad Autónoma de Buenos Aires , Buenos Aires
Australia (1)
Royal Prince Alfred Hospital
Camperdown , New South Wales
Belgium (1)
UZ Antwerpen
Edegem , Antwerpen
Chile (1)
Centro de especialidades médicas Vanguardia
Temuco , Araucania
Croatia (1)
Clinical Hospital Dubrava
Zagreb , City of Zagreb
Czech Republic (1)
Fakultni nemocnice v Motole
Prague , Praha, Hlavní Mesto
Denmark (1)
Odense Universitetshospital
Odense , Fyn
Finland (1)
Kuopion yliopistollinen sairaala
Kuopio , Northern Savonia
France (1)
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg , Bas-Rhin
Greece (1)
University General Hospital of Alexandroupolis
Alexandroupoli
Hungary (1)
Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
Pécs , Baranya
India (1)
Nizam's Insti. of Medical Sciences
Hyderabad
Italy (1)
Università degli Studi G. D'Annunzio Chieti-Pescara
Chieti , Abruzzo
Mexico (1)
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
Mexico City
Netherlands (1)
Kempenhaeghe - PPDS
Heeze , North Brabant
Poland (1)
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan , Greater Poland Voivodeship
Romania (1)
Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50
Târgu Mureş , Mureș County
Slovakia (1)
IN MEDIC, s.r.o.
Bardejov
South Africa (1)
InnoMed Clinical Trial Centre
Cape Town , Western Cape
Spain (1)
Hospital Universitario Germans Trias i Pujol
Badalona , Barcelona
Switzerland (1)
Klinik Lengg AG
Zurich , Zürich (de)
United Kingdom (1)
Morriston Hospital
Swansea , Glamorgan
United States (1)
Accel Research
Birmingham , Alabama
Technical details
Status
By invitation only
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
30.07.2024
Completion date
01.01.2027
Registry ID
NCT06443463
Source
anzctr
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