PROOF-HD

PROOF-HD

Pridopidine Outcome On Function in Huntington Disease

Recruiting

SPONSOR

Prilenia Neurotherapeutics & Huntington Study Group

PARTICIPANTS

480 participants

PROOF-HD is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of pridopidine in patients with early stage of Huntington disease.

Estimated Primary Completion: March 3, 2023

Ages Eligible for Study:

25 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Inclusion Criteria Main Study

  1. Diagnosis of HD based on clinical features and the presence of ≥36 CAG repeats in the huntingtin gene
  2. Diagnostic confidence level (DCL) of 4
  3. Adult-onset HD with onset of signs and symptoms ≥18 years of age
  4. Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of ≥7, at screening

Exclusion Criteria

  1. Use of pridopidine within 12 months before the baseline visit.
  2. Gene therapy at any time
  3. 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
  4. History of epilepsy or seizures within the last 5 years
  5. Pregnant or breastfeeding, or intention to become pregnant during the study

COUNTRIES

Updates:

The new Article of HDBuzz “Scientists identify precisely how pridopidine works in models of Huntington’s disease” by Dr Rachel Harding brings exciting news about PROOF-HD potential study.
 
 

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

TRIAL SITE: Centre Hospitalier Universitaire (CHU) Amiens-Picardie

Adress: Amiens

TRIAL SITE:Centre Hospitalier Universitaire (CHU) de Bordeaux

Adress: Bordeaux

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

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

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: 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: Burgos Foundation for Health Research

Adress: Burgos

Contact: Tel:  +34 947 28 18 00 ext 35380
Email: jessicajrp@hubu.es

mcubo@saludcastillayleon.es

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: Barberry National Centre for Mental Health

Adress: Birmingham (England)

TRIAL SITE: Cardiff University

Adress: Cardiff (Wales)