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NCT06976268Not yet recruitingPhase 2/3

A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease

A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants with Early Parkinson’s Disease

Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Aug 2026

Brief summary (registry, in English)

To evaluate the efficacy of 2 dose levels of BHV-8000 compared to placebo by delaying the time to the first qualifying worsening event on the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
713 (estimated)
First submitted
25 Aug 2025
Start date
10 Sept 2025
Lead sponsor
Biohaven Therapeutics Ltd.
NCT number
NCT06976268
EU CT number
2025-521113-13-00

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 713
  • 101 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with PD medication(s)

Other illness

  • Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including, but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced Parkinsonism, essential tremor, or primary dystonia.
  • Diagnosis of clinically significant central nervous system (CNS) disease other than PD.
  • Any other condition(s) that may compromise participant safety, interfere with study conduct, or jeopardize the potential proper interpretation of study results, in the opinion of the investigator.

Other

  • Participants who are current smokers (defined as smoking [in any form, e.g., tobacco smoke, electronic cigarettes, etc.] ).

Who the study is looking for

  • Male or female participants 40 to 85 years of age, inclusive, at the time of informed consent
  • Meet the diagnostic criteria for "Probable PD" as assessed on the Movement Disorder Society(MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator.
  • Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 years of the Screening Visit

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (101)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaNot yet recruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
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SalzburgAustriaNot yet recruiting
University of Antwerp
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AntwerpBelgiumNot yet recruiting
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumNot yet recruiting
UZ Leuven
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LeuvenBelgiumNot yet recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumNot yet recruiting
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaNot yet recruiting
NEUROHK s r o
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ChoceňCzechiaNot yet recruiting
Nemocnice Jihlava prispevkova organizace
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Jihlava 1CzechiaNot yet recruiting
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
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Bad HomburgGermanyNot yet recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyNot yet recruiting
Alexianer St Joseph Berlin-Weissensee GmbH
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BerlinGermanyNot yet recruiting
Katholisches Klinikum Bochum gGmbH
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BochumGermanyNot yet recruiting
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
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BonnGermanyNot yet recruiting
University Hospital Cologne AöR
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CologneGermanyNot yet recruiting
Technische Universitaet Dresden
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DresdenGermanyNot yet recruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyNot yet recruiting
Curiositas ad sanum Studien und Beratungs GmbH
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EbersbergGermanyNot yet recruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyNot yet recruiting
Praxis MD Oehlwein
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GeraGermanyNot yet recruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyNot yet recruiting
Medizinische Hochschule Hannover
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HanoverGermanyNot yet recruiting
Universitaet Des Saarlandes
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HomburgGermanyNot yet recruiting
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA
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KasselGermanyNot yet recruiting
Universitaet Leipzig
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LeipzigGermanyNot yet recruiting
Philipps-Universitaet Marburg
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MarburgGermanyNot yet recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyNot yet recruiting
LMU Klinikum Muenchen AöR
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MunichGermanyNot yet recruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyNot yet recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyNot yet recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyNot yet recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainNot yet recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainNot yet recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainNot yet recruiting
Hospital Universitario De Burgos
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BurgosSpainNot yet recruiting
Policlinica Gipuzkoa S.A.
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DonostiaSpainNot yet recruiting
Hospital General Universitario de Elche
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ElcheSpainNot yet recruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainNot yet recruiting
Hospital Ruber Internacional
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MadridSpainNot yet recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainNot yet recruiting
Hospital Universitario HM Puerta del Sur
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MóstolesSpainNot yet recruiting
Clínica Universidad de navarra
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PamplonaSpainNot yet recruiting
Hospital Universitario Infanta Sofia
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San Sebastián de los ReyesSpainNot yet recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainNot yet recruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceNot yet recruiting
CHU Besançon
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BesançonFranceNot yet recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceNot yet recruiting
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
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BronFranceNot yet recruiting
Caen University Hospital
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CaenFranceNot yet recruiting
CHU Henri Mondor
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Créteil CedexFranceNot yet recruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceNot yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceNot yet recruiting
CHU De Lille, Hôpital Roger Salengro
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LilleFranceNot yet recruiting
Hôpital de la Timone
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Marseille Cedex 5FranceNot yet recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceNot yet recruiting
CHU de Nantes - Hôpital Laennec
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Nantes Cedex 1FranceNot yet recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceNot yet recruiting
CHU Caremeau Service de Neurologie
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NîmesFranceNot yet recruiting
Institut Du Cerveau Et De La Moelle Epiniere
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ParisFranceNot yet recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceNot yet recruiting
Hôpital Pontchaillou-CHU Rennes
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Rennes Cedex 09 FranceFranceNot yet recruiting
CHU de Rouen - Hôpital Charles Nicolle
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RouenFranceNot yet recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceNot yet recruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceNot yet recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyNot yet recruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyNot yet recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyNot yet recruiting
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
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MilanItalyNot yet recruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyNot yet recruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyNot yet recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyNot yet recruiting
Azienda Ospedaliera di Padova
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PadovaItalyNot yet recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyNot yet recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyNot yet recruiting
Irccs San Raffaele Roma S.r.l.
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RomeItalyNot yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyNot yet recruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyNot yet recruiting
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
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SalernoItalyNot yet recruiting
Brain Research Center Amsterdam B.V.
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AmsterdamNetherlandsNot yet recruiting
UMCG
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GroningenNetherlandsNot yet recruiting
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsNot yet recruiting
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsNot yet recruiting
Brain Research Center Den Bosch B.V.
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's-HertogenboschNetherlandsNot yet recruiting
Centrum Medyczne Neuromed Sp. z.o.o.
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BydgoszczPolandNot yet recruiting
Pratia S.A.
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CracowPolandNot yet recruiting
Linden Sp. z o.o. sp.k.
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CracowPolandNot yet recruiting
ETG Lublin Sp. z o.o.
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DebicaPolandNot yet recruiting
Neuro-Care Sp. z o.o. sp.k.
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KatowicePolandNot yet recruiting
Silmedic Sp. z o.o.
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KatowicePolandNot yet recruiting
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
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LublinPolandNot yet recruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
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OswiecimPolandNot yet recruiting
Centrum Medyczne HCP Sp. z o.o.
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PoznanPolandNot yet recruiting
RCMed Oddzial Sochaczew
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SochaczewPolandNot yet recruiting
ETG Neuroscience Sp. z o.o.
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WarsawPolandNot yet recruiting
Centrum Medyczne NeuroProtect
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WarsawPolandNot yet recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalNot yet recruiting
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalNot yet recruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalNot yet recruiting
CNS Saude Lda.
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Torres VedrasPortugalNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.