Clinical trial • Phase I • Neurology|Rare Disease

ALN-HTT02 for Huntington's disease

Phase I trial of ALN-HTT02 for Huntington's disease. 46 participants.

Overview

Trial Therapeutic Area
Neurology|Rare Disease
Trial Disease
Huntington's disease
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
10-10-2024
First CTIS Authorization Date
23-12-2024

Trial design

Phase I trial across 7 sites in Germany.

Target Sample Size
46

Eligibility

Recruits 46 Vulnerable population selected (isVulnerablePopulationSelected = true). No further information on consent or assent handling provided in the record..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). No further information on consent or assent handling provided in the record.

Recruitment

Planned Sample Size
46
Recruitment Window Months
69

Geography

Total Number Of Sites
7
Total Number Of Participants
46

Germany

Earliest CTIS Part Ii Submission Date
29-11-2024
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
475
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Technische Universitaet Dresden
Department Name
Klinik für Neurologie
Principal Investigator Name
Björn Falkenburger
Principal Investigator Email
bjoern.falkenburger@ukdd.de
Contact Person Name
Björn Falkenburger
Contact Person Email
bjoern.falkenburger@ukdd.de
Site Name
Kbo Isar-Amper-Klinikum Taufkirchen (Vils)
Department Name
-
Principal Investigator Name
Alzbeta Muehlbaeck
Principal Investigator Email
alzbeta.muehlbaeck@kbo.de
Contact Person Name
Alzbeta Muehlbaeck
Contact Person Email
alzbeta.muehlbaeck@kbo.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Psychiatrie und Psychotherapie
Principal Investigator Name
Josef Priller
Principal Investigator Email
josef.priller@charite.de
Contact Person Name
Josef Priller
Contact Person Email
josef.priller@charite.de
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
-
Principal Investigator Name
Carsten Saft
Principal Investigator Email
carsten.saft@rub.de
Contact Person Name
Carsten Saft
Contact Person Email
carsten.saft@rub.de
Site Name
George-Huntington-Institut GmbH
Department Name
-
Principal Investigator Name
Ralf Reilmann
Principal Investigator Email
ralf.reilmann@ghi-muenster.de
Contact Person Name
Ralf Reilmann
Contact Person Email
ralf.reilmann@ghi-muenster.de
Site Name
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Department Name
-
Principal Investigator Name
Patrick Weydt
Principal Investigator Email
patrick.weydt@ukbonn.de
Contact Person Name
Patrick Weydt
Contact Person Email
patrick.weydt@ukbonn.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Huntington Ambulanz
Principal Investigator Name
Katrin Lindenberg
Principal Investigator Email
katrin.lindenberg@uni-ulm.de
Contact Person Name
Katrin Lindenberg
Contact Person Email
katrin.lindenberg@uni-ulm.de

Sponsor

Primary sponsor

Full Name
Alnylam Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
ALN-HTT02

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