PROOF-HD
Active, Not Recruiting
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
Czech Republic
TRIAL SITE: Centrum extrapyramidových onemocnění
Address: Prague
France
TRIAL SITE: Centre Hospitalier Universitaire (CHU) Henri Mondor
Address: Paris
TRIAL SITE:Hôpitaux Universitaires de Marseille Timone
Address: Marseille
TRIAL SITE: Centre Hospitalier Universitaire (CHU) of Lille – Hôpital Roger Salengro
Address: Lille
Germany
TRIAL SITE: Euregional Huntington Center Aachen (EHZA)
Address: Aachen
TRIAL SITE: George Huntington Institut
Address: Münster
TRIAL SITE: Huntington Center North Rhine-Westphalia,
Department of Neurology,
Ruhr-University Bochum,
St. Josef-Hospital Bochum
Address: Bochum
TRIAL SITE: Kbo-Isar-Amper-Klinikum Taufkirchen (Vils)
Address: Taufkirchen (Vils)
TRIAL SITE: University of Lübeck
Address: Lübeck
TRIAL SITE: Ulm University
Address: Ulm
Italy
TRIAL SITE: IRCCS Istituto delle Scienze Neurologiche di Bologna
Address: Bologna
TRIAL SITE: Fondazione IRCCS Istituto Neurologico Carlo Besta
Address: Milano
TRIAL SITE: CSS-Mendel Institute at IRCCS Casa Sollievo della Sofferenza Research Hospital
Address: Roma
TRIAL SITE:Universita’ di Bari
Address: Bari
TRIAL SITE:Università di Napoli Federico II
Address: Naples
The Netherlands
TRIAL SITE: Maastricht University
Address: Maastricht
TRIAL SITE:Leiden University Medical Center
Address: Leiden
Poland
TRIAL SITE: Szpital Specjalistyczny Swietego Wojciecha
Address: Gdansk
TRIAL SITE: Krakowska Akademia Neurologii
Address: Krakow
TRIAL SITE:Instytut Psychiatrii i Neurologii
Address: Warsaw
Spain
TRIAL SITE:Hospital de la Santa Creu i Sant Pau
Address: Barcelona
TRIAL SITE: Burgos Foundation for Health Research
Address: Burgos
TRIAL SITE: Fundacion Hospital Universitario La Fé
Address: Valencia
TRIAL SITE:Hospital Ramón y Cajal
Address: Madrid
United Kingdom
TRIAL SITE: Cardiff University
Address: Cardiff , Wales
TRIAL SITE: Aberdeen University
Address: Aberdeen, Scotland
TRIAL SITE: Newcastle upon Tyne Hospitals NHS Foundation
Address:Newcastle, England