PROOF-HD
Completed
Updates:
PROOF-HD is a Phase 3 clinical study that evaluates the efficacy and safety of pridopidine in patients with early stage of Huntington Disease. Pridopidine is a small molecule developed by Prilenia for the treatment of neurodegenerative disorders such as HD.
According to Prilenia, the Pridopidine is an oral drug administered in a small easy-to-swallow capsule twice a day, which enters the brain and spinal cord, where it activates a protein called the sigma-1 receptor (S1R). Activation of the S1R by pridopidine enhances the clearance of toxic proteins, enhances energy production, and reduces cellular stress and inflammation. These mechanisms are crucial for a neuron’s function and survival.
Webinar: Understanding PROOF-HD results
Webinar: All you need to know about PROOF HD
Dr. Michael Hayden presents Phase 3 PROOF-HD
Ages Eligible
for Study:
25 Years and older
(Adult, Older Adult)
Sexes Eligible
for Study:
All
Accepts Healthy Volunteers:
No
- Diagnosis of HD based on clinical features and the presence of ≥36 CAG repeats in the huntingtin gene
- Diagnostic confidence level (DCL) of 4
- Adult-onset HD with onset of signs and symptoms ≥18 years of age
- Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of ≥7, at screening
- Use of pridopidine within 12 months before the baseline visit.
- Gene therapy at any time
- Any serious medical condition or clinically significant laboratory, or vital sign abnormality that precludes the patient’s safe participation in and completion of the study e.g. significant heart disease within 12 weeks before baseline or history of certain cardiac arrhythmias
- History of epilepsy or seizures within the last 5 years
- Pregnant or breastfeeding, or intention to become pregnant during the study
COUNTRIES
COUNTRIES
Austria
TRIAL SITE: Medizinische Universität Innsbruck
Adress: Innsbruck
Contact: Dora Valent, Study Site Coordinator
Phone: 0512 504 83237
Email: dora.valent@tirol-kliniken.at
Czech Republic
TRIAL SITE: Centrum extrapyramidových onemocnění
Adress: Prague
Contact: Jiri Klempir, MD, Study Site Investigator
Tel: +420 732 273 271
Email: Jiri.Klempir@seznam.cz
France
TRIAL SITE: Centre Hospitalier Universitaire (CHU) Henri Mondor
Adress: Paris
Contact: Tiffany Monnier, Study Site Coordinator
Tel. 01.49.81.37.93
TRIAL SITE:Hôpitaux Universitaires de Marseille Timone
Adress: Marseille
Contact: Email: Laura Laura.MUNDLER@ap-hm.fr
TRIAL SITE: Centre Hospitalier Universitaire (CHU) of Lille – Hôpital Roger Salengro
Adress: Lille
Contact: Eric Decorte, Study Site Coordinator
Email: eric.decorte@chru-lille.fr
Germany
TRIAL SITE: Euregional Huntington Center Aachen (EHZA)
Adress: Aachen
Contact: Maha Sagar, Study Site Coordinator, Email: NeuroStudien@ukaachen.de Tel: +49 241 80 80697
TRIAL SITE: George Huntington Institut
Adress: Münster
Contact: Tel: +49 251 7887880
Email: info@ghi-muenster.de
TRIAL SITE: Huntington Center North Rhine-Westphalia,
Department of Neurology,
Ruhr-University Bochum,
St. Josef-Hospital Bochum
Adress: Bochum
Contact: Email: d.kaminski@klinikum-bochum.de
Tel.: +49-234-509-2703
TRIAL SITE: Kbo-Isar-Amper-Klinikum Taufkirchen (Vils)
Adress: Taufkirchen (Vils)
Contact: Michael Bachmaier, Study Site Coordinator
Email: Michael.Bachmaier@kbo.de
Tel: 08084-934-417
TRIAL SITE: University of Lübeck
Adress: Lübeck
Contact: Saruhi Surnaschjan, Study Site Coordinator
Phone:+49 451 50043497
Email: saruhi.surnaschjan@neuro.uni-luebeck.de
TRIAL SITE: Ulm University
Adress: Ulm
Contacts:
Sonja Trautmann
Tel: +49 731 50063083
Ariane Schneider
Tel: +49 731 50063126
Italy
TRIAL SITE: IRCCS Istituto delle Scienze Neurologiche di Bologna
Adress: Bologna
Contact: Tel: +393387367104
Email: unitastudiclinici@ausl.bologna.it
TRIAL SITE: Fondazione IRCCS Istituto Neurologico Carlo Besta
Adress: Milano
Contact: Tel: +39 02 23942519
Email: centroHD@istituto-besta.it
TRIAL SITE: CSS-Mendel Institute at IRCCS Casa Sollievo della Sofferenza Research Hospital
Adress: Roma
Contact: Tel: +39 06 44700887
Email: info@lirh.it
TRIAL SITE:Universita’ di Bari
Adress: Bari
TRIAL SITE:Università di Napoli Federico II
Adress: Naples
Contact: Email: centrohd.unina@gmail.com
Tel: +39 081 5455213
The Netherlands
TRIAL SITE: Maastricht University
Adress: Maastricht
Contact: Dr. Mayke Oosterloo, Study Site Investigator
Tel: 0031-(0)43-387 76 76, Email: expertisecentrumhuntington@mumc.nl
TRIAL SITE:Leiden University Medical Center
Adress: Leiden
Contact: Tel: 0031715265442
Email: huntington@lumc.nl
Poland
TRIAL SITE: Szpital Specjalistyczny Swietego Wojciecha
Adress: Gdansk
Contact: Agnieszka Konkel, Study Site Coordinator
Tel: +48 609 952 555
Email: konkel1989@gmail.com
TRIAL SITE: Krakowska Akademia Neurologii
Adress: Krakow
Contact: Email: centrum@neurologia.org.pl
Tel: +48 12 426 92 80
TRIAL SITE:Instytut Psychiatrii i Neurologii
Adress: Warsaw
Contact: Grzegorz Witkowski, Study Site Investigator
Email: gwitkowski@ipin.edu.pl
Phone: +48694904208
Spain
TRIAL SITE:Hospital de la Santa Creu i Sant Pau
Adress: Barcelona
Contact: Dr. Jaime Kulisevsky
Email: JKulisevsky@santpau.cat
Tel: +34 649 14 23 60
TRIAL SITE: Burgos Foundation for Health Research
Adress: Burgos
Contact: Tel: +34 947 28 18 00 ext 35380
Email: jessicajrp@hubu.es,
TRIAL SITE: Fundacion Hospital Universitario La Fé
Adress: Valencia
Contact: Francisco Castera, Study Site Coordinator
Email: franciscocasteraenroll@gmail.com
Carmen PEIRO, Study Site Investigator. Email: cpeirov@gmail.com
Tel: Phone: +34 682893185
TRIAL SITE:Hospital Ramón y Cajal
Adress: Madrid
Contact: Email: joselopezsendon@hotmail.com
Tel: +34 638 158 849
United Kingdom
TRIAL SITE: University of Aberdeen, Institute of Medical Sciences
Adress: Aberdeen (Scotland)
Contact: Stella Sihlabela, Study Site Coordinator
Tel: +44 1224 552120
Email: stella.sihlabela@nhs.scot
Resifina Seyara, Study Site Coordinator
Tel: +44 1224 552120
Email: resifina.seyara@nhs.scot
TRIAL SITE: Cardiff University
Adress: Cardiff (Wales)
Contact: Alison Johnson, Study Site Coordinator
Email: Alison.Johnson@wales.nhs.uk
TRIAL SITE: Barberry National Centre for Mental Health
Adress: Birmingham (England)
TRIAL SITE: Newcastle upon Tyne Hospitals NHS Foundation
Adress:Newcastle (England)
