Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
66
Countries
1
Sites
7
Huntington’s disease
Key facts
- Sponsor
- Alnylam Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 7 Mar 2025 → ongoing
- Decision date (initial)
- 2024-12-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515732-68-00
- ClinicalTrials.gov
- NCT06585449
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Huntington’s disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10070668 | Huntington's disease | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alnylam Pharmaceuticals Inc.
- Sponsor organisation
- Alnylam Pharmaceuticals Inc.
- Address
- 300 3rd Street
- City
- Cambridge
- Postcode
- 02142-1103
- Country
- United States
Scientific contact point
- Organisation
- Alnylam Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Alnylam Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 20 | 7 |
| Rest of world
United Kingdom, Canada, United States
|
— | 46 | — |
Investigational sites
Kbo Isar-Amper-Klinikum Taufkirchen (Vils)
-, Braeuhausstrasse 5, 84416, Taufkirchen/Vils
Technische Universitaet Dresden
Klinik für Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
-, Venusberg-Campus 1/99, Venusberg, Bonn
Katholisches Klinikum Bochum gGmbH
-, Gudrunstrasse 56, Grumme, Bochum
George-Huntington-Institut GmbH
-, Wilhelm-Schickard-Strasse 15, Sentrup, Muenster
Universitaetsklinikum Ulm AöR
Huntington Ambulanz, Oberer Eselsberg 45, Eselsberg, Ulm
Charite Universitaetsmedizin Berlin KöR
Klinik für Psychiatrie und Psychotherapie, Chariteplatz 1, Mitte, Berlin
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2025-03-07 | 2025-04-10 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Germany | Acceptable 2024-12-17
|
2024-12-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-31 | Germany | Acceptable 2025-04-22
|
2025-05-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-20 | Germany | Acceptable 2025-04-22
|
2025-06-20 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-21 | Germany | Acceptable 2025-04-22
|
2025-11-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-02 | Germany | Acceptable 2026-03-19
|
2026-03-19 |