Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
79
Countries
6
Sites
16
Huntington’s Disease Gene Expansion Carriers
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2026-05-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Huntington’s Disease Gene Expansion Carriers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10070668 | Huntington´s disease | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
6 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 3 | 1 |
| Germany | Authorised, recruitment pending | 12 | 4 |
| Italy | Authorised, recruitment pending | 4 | 2 |
| Poland | Authorised, recruitment pending | 6 | 3 |
| Portugal | Authorised, recruitment pending | 6 | 2 |
| Spain | Authorised, recruitment pending | 12 | 4 |
| Rest of world
Argentina, United Kingdom, Australia, Canada, New Zealand
|
— | 36 | — |
Investigational sites
Rigshospitalet
Clinical Research, Blegdamsvej 9, 2100, Copenhagen Oe
Universitaetsklinikum Erlangen AöR
Molekular-Neurologische Abteilung, Schwabachanlage 6, Innenstadt, Erlangen
Universitaetsklinikum Ulm AöR
Klinik für Neurologie, Oberer Eselsberg 45, Eselsberg, Ulm
Charite Universitaetsmedizin Berlin KöR
Klinik für Psychiatrie und Psychotherapie, Chariteplatz 1, Mitte, Berlin
Katholisches Klinikum Bochum gGmbH
Forschungszentrum für Neurodegeneration, Gudrunstrasse 56, Grumme, Bochum
Azienda Ospedaliero Universitaria Careggi
Clinical Trial Unit 1, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
IRCCS Foundation Istituto Neurologico Carlo Besta
Unità di Fase I, Via Giovanni Celoria 11, 20133, Milan
Copernicus Podmiot Leczniczy Sp. z o.o.
Szpital Św. Wojciecha, Kliniczny Oddział Neurologiczny/ Udarowy GUmed, Al. Jana Pawla II 50, 80-462, Gdansk
Mtz Clinical Research Powered By Pratia
MTZ Clinical Research Powered by Pratia, Ul. Gładka 22, 02-172, Warsaw
Wojskowy Instytut Medycyny Lotniczej
Wojskowy Instytut Medycyny Lotniczej, Ul. Zygmunta Krasinskiego 54/56, 01-755, Warsaw
CCAB Centro Clinico Academico Braga Associacao
Neurology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Santa Maria E.P.E.
Neurology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Hospital Universitario De Badajoz
Neurology, Avenida Elvas S/n, 06006, Badajoz
Hospital De La Santa Creu I Sant Pau
Neurology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario De Burgos
Neurology, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital Universitario Ramon Y Cajal
Neurology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-20 | Denmark | Acceptable 2026-05-11
|
2026-05-11 |