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 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.

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

Canada

TRIAL SITE: University of Calgary

Adress: Calgary

Contact: Lorelei Tainsh, Study Site Coordinator
Phone: (403) 220-8413
Email: derwent@ucalgary.ca

TRIAL SITE:University of British Columbia

Adress: Vancouver

Contact: Mike Adurogbangba, Study Site Coordinator
Email: madurogbangba@cmmt.ubc.ca
Phone: (604) 822-4872

TRIAL SITE:Halifax Infirmary QEII Health Services Center

Adress: Halifax

Contact: Madie El-aghil, Study Site Coordinator
Phone: (902) 431-8783 Ext: 115
Email: madie.el-aghil@truenorthcr.com

TRIAL SITE: CHUM Hospital of Notre Dame

Adress: Montreal

Contact: Vicky Thiffault, Study Site Coordinator
Phone: (514) 890-8000, ext 15921
Email: vicky.thiffault.chum@ssss.gouv.qc.ca

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

mcubo@saludcastillayleon.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)

United States

TRIAL SITE: University of California, Davis (UC Davis) Medical Center

Adress: Sacramento

Contact: Becky Craig, Study Site Coordinator
Phone: (916) 734-3541
Email: rscraig@ucdavis.edu

TRIAL SITE: University of California, San Diego (UCSD)

Adress: San Diego

Contact: Email: jcoreybloom@ucsd.edu
Phone: (858) 249-0569

TRIAL SITE: Rocky Mountain Movement Disorder Center

Adress: Englewood

Contact: Jessica Jaynes, Study Site Coordinator
Phone: (303) 357-5456

TRIAL SITE:Georgetown University

Adress: Washington

Contact: Robin Kuprewicz, Study Site Coordinator
Phone: (202) 893-1115
Email: rk1028@georgetown.edu

TRIAL SITE: University of Florida

Adress: Gainesville

Contact: Kyle Rizer, Study Site Coordinator
Phone: (352) 733-2426
Email: kyle.rizer@neurology.ufl.edu

TRIAL SITE:University of South Florida

Adress: Tampa

Contact: Kelly (Kolleen) Elliott, Study Site Coordinator
Email: kelliot@usf.edu  

TRIAL SITE: Emory University

Adress: Atlanta

Contact: Elaine Sperin, Study Site Coordinator
Email: esperin@emory.edu

TRIAL SITE: Northwestern University

Adress: Chicago

Contact:ZsaZsa Brown, Study Site Coordinator
Phone: (312) 503-4121
Email: zsazsa.brown@northwestern.edu

TRIAL SITE: University of Kansas Medical Center

Adress: Kansas City

Contact: Carolyn Gray, Study Site Coordinator
Phone: (913) 588-6983
Email: cgray1@kumc.edu

TRIAL SITE: Hereditary Neurological Disease Centre

Adress: Wichita

Contact:Gregory Suter, Study Site Coordinator
Phone: (888) 232-4632

TRIAL SITE: University of Louisville

Adress: Louisville

Contact: Annette Robinson, Study Site Coordinator
Email: annette.robinson@louisville.edu

TRIAL SITE: Johns Hopkins University

Adress: Baltimore

Contact: Kia Ultz, Study Site Coordinator
Phone: (410) 955-1349
Email: kcarte23@jhmi.edu

TRIAL SITE:Beth Israel Deaconess Medical Center

Adress: Boston

Contact: Sophie Antonioli, Study Site Coordinator
Phone: (617) 667-2355
Email: hdresearch@bidmc.harvard.edu

TRIAL SITE:Massachusetts General Hospital

Adress: Boston

Contact:Dr. Diana Rosas, Study Site Investigator
Phone: (617) 726-9045

TRIAL SITE:Washington University, St. Louis

Adress: St. Louis

Contact: Matthew Lewis, Study Recruitment
Phone: (314) 747-5916
Email: lmatthew@wustl.edu

TRIAL SITE: Albany Medical College

Adress: Albany

Contact: Email: evanss@amc.edu

TRIAL SITE:Columbia University

Adress: New York City

Contact: Miles DeGrazia, Study Site Coordinator
Email: MQD2103@cumc.columbia.edu

TRIAL SITE: Duke University

Adress: Durham

Contact: McKenzie Luxmore, Study Site Coordinator
Email: mckenzie.luxmore@duke.edu
Phone: (919) 684-0865

TRIAL SITE: University of Cincinnati

Adress: Cincinnati

Contact:Christina Gruenwald, Study Site Coordinator
Phone: (513) 558-0112
Email: gruenwcm@ucmail.uc.edu

TRIAL SITE: Ohio State University

Adress: Columbus

Contact: Casey Mitchell, Study Site Coordinator
Email: casey.mitchell@osumc.edu
Phone:  (614) 685-9906

Katherine Ambrogi, Study Site Coordinator
Email: katherine.ambrogi@osumc.edu
Phone: (614) 688-6685

TRIAL SITE: Oregon Health & Sciences University

Adress: Portland

Contact: Keenan Ashby, Study Site Coordinator
Phone: (503) 494-7245
Email: ashbyk@ohsu.edu

TRIAL SITE: University of Pennsylvania

Adress: Philadelphia

Contact: Jennifer Klapper, Study Site Coordinator
Phone: (215) 829-5176

TRIAL SITE: Vanderbilt University Medical Center

Adress: Nashville

Contact: Dr. Daniel Claassen, Study Site Investigator
Danielle Buchanan, Study Site Coordinator
Email: danielle.a.buchanan@vumc.org
Phone: (615) 875-3274

TRIAL SITE: University of Texas, Houston

Adress: Houston

Contact: Jamie Sims, Study Site Coordinator
Phone: 713-500-7763
Email: Jamie.Sims@uth.tmc.edu

TRIAL SITE:Virginia Commonwealth University

Adress: Richmond

Contact:Kelly Huckstep, Study Site Coordinator
Phone: (804) 965-4283
Email: kelly.huckstep@vcuhealth.org

TRIAL SITE: University of Washington

Adress:Seattle

Contact:Debra Del Castillo, Study Site Coordinator
Phone: (206) 543-3647
Email: debradel@uw.edu

TRIAL SITE: University of Texas, Houston

Adress: Houston

Contact: Jamie Sims, Study Site Coordinator
Phone: 713-500-7763
Email: Jamie.Sims@uth.tmc.edu