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.
- Diseases
- Parkinson disease
- 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
Sites (101)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Not yet recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Not yet recruiting |
| University of Antwerp Coordinator of this site? Confirm its status | Antwerp | Belgium | Not yet recruiting |
| Algemeen Ziekenhuis Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Not yet recruiting |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Not yet recruiting |
| NEUROHK s r o Coordinator of this site? Confirm its status | Choceň | Czechia | Not yet recruiting |
| Nemocnice Jihlava prispevkova organizace Coordinator of this site? Confirm its status | Jihlava 1 | Czechia | Not yet recruiting |
| Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Coordinator of this site? Confirm its status | Bad Homburg | Germany | Not yet recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Alexianer St Joseph Berlin-Weissensee GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Not yet recruiting |
| Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. Coordinator of this site? Confirm its status | Bonn | Germany | Not yet recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Not yet recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Not yet recruiting |
| Curiositas ad sanum Studien und Beratungs GmbH Coordinator of this site? Confirm its status | Ebersberg | Germany | Not yet recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Not yet recruiting |
| Praxis MD Oehlwein Coordinator of this site? Confirm its status | Gera | Germany | Not yet recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Not yet recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Not yet recruiting |
| Universitaet Des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Not yet recruiting |
| Paracelsus-Kliniken Deutschland GmbH & Co. KGaA Coordinator of this site? Confirm its status | Kassel | Germany | Not yet recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| Philipps-Universitaet Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Not yet recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Not yet recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Not yet recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Not yet recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Not yet recruiting |
| Policlinica Gipuzkoa S.A. Coordinator of this site? Confirm its status | Donostia | Spain | Not yet recruiting |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Not yet recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| Hospital Ruber Internacional Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Not yet recruiting |
| Hospital Universitario HM Puerta del Sur Coordinator of this site? Confirm its status | Móstoles | Spain | Not yet recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Not yet recruiting |
| Hospital Universitario Infanta Sofia Coordinator of this site? Confirm its status | San Sebastián de los Reyes | Spain | Not yet recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Not yet recruiting |
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Not yet recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Hospices Civils de Lyon - Hôpital Pierre Wertheimer Coordinator of this site? Confirm its status | Bron | France | Not yet recruiting |
| Caen University Hospital Coordinator of this site? Confirm its status | Caen | France | Not yet recruiting |
| CHU Henri Mondor Coordinator of this site? Confirm its status | Créteil Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Not yet recruiting |
| CHU De Lille, Hôpital Roger Salengro Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Hôpital de la Timone Coordinator of this site? Confirm its status | Marseille Cedex 5 | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Not yet recruiting |
| CHU de Nantes - Hôpital Laennec Coordinator of this site? Confirm its status | Nantes Cedex 1 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Not yet recruiting |
| CHU Caremeau Service de Neurologie Coordinator of this site? Confirm its status | Nîmes | France | Not yet recruiting |
| Institut Du Cerveau Et De La Moelle Epiniere Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Not yet recruiting |
| Hôpital Pontchaillou-CHU Rennes Coordinator of this site? Confirm its status | Rennes Cedex 09 France | France | Not yet recruiting |
| CHU de Rouen - Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Not yet recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Not yet recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Not yet recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Not yet recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Not yet recruiting |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona Coordinator of this site? Confirm its status | Salerno | Italy | Not yet recruiting |
| Brain Research Center Amsterdam B.V. Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Not yet recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Not yet recruiting |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| Brain Research Center Den Bosch B.V. Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Not yet recruiting |
| Centrum Medyczne Neuromed Sp. z.o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Not yet recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Linden Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| ETG Lublin Sp. z o.o. Coordinator of this site? Confirm its status | Debica | Poland | Not yet recruiting |
| Neuro-Care Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| Silmedic Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Oswiecim | Poland | Not yet recruiting |
| Centrum Medyczne HCP Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Not yet recruiting |
| RCMed Oddzial Sochaczew Coordinator of this site? Confirm its status | Sochaczew | Poland | Not yet recruiting |
| ETG Neuroscience Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Not yet recruiting |
| Unidade Local De Saude Do Alto Ave E.P.E. Coordinator of this site? Confirm its status | Guimaraes | Portugal | Not yet recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
| CNS Saude Lda. Coordinator of this site? Confirm its status | Torres Vedras | Portugal | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.