Clinical trial • Phase I • Neurology

ION464 for Multiple system atrophy

Phase I trial of ION464 for Multiple system atrophy. 65 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Multiple system atrophy
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
04-07-2024
First CTIS Authorization Date
14-08-2024

Trial design

Phase I trial across 11 sites in Germany, Portugal, Austria and others.

Target Sample Size
65

Recruitment

Planned Sample Size
65
Recruitment Window Months
108

Geography

Total Number Of Sites
11
Total Number Of Participants
65

Germany

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
492
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Philipps-Universitaet Marburg
Department Name
Neurology
Principal Investigator Name
Karla Eggert
Principal Investigator Email
eggert@med.uni-marburg.de
Contact Person Name
Karla Eggert
Contact Person Email
eggert@med.uni-marburg.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Neurology
Principal Investigator Name
Guenter Hoeglinger
Principal Investigator Email
Guenter.Hoeglinger@med.uni-muenchen.de
Contact Person Name
Guenter Hoeglinger
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Neurology
Principal Investigator Name
Alfons Schnitzler
Principal Investigator Email
schnitza@med.uni-duesseldorf.de
Contact Person Name
Alfons Schnitzler
Site Name
Universitaetsmedizin Goettingen
Department Name
Neurology
Principal Investigator Name
Christoph van Riesen
Principal Investigator Email
christoph.van-riesen@med.uni-goettingen.de
Contact Person Name
Christoph van Riesen
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Neurology
Principal Investigator Name
Georg Bernhard Landwehrmeyer
Principal Investigator Email
bernhard.landwehrmeyer@uni-ulm.de
Contact Person Name
Georg Bernhard Landwehrmeyer
Site Name
Medizinische Hochschule Hannover
Department Name
Neurology
Principal Investigator Name
Guenter Hoeglinger
Principal Investigator Email
Hoeglinger.Guenter@mh-hannover.de
Contact Person Name
Guenter Hoeglinger

Portugal

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
491
Number Of Sites
1
Number Of Participants
12

Sites

Site Name
Hospital De Loures EPE
Department Name
Neurology
Principal Investigator Name
Rita Simões
Principal Investigator Email
rita.simoes@hbeatrizangelo.pt
Contact Person Name
Rita Simões
Contact Person Email
rita.simoes@hbeatrizangelo.pt

Austria

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
497
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Neurology
Principal Investigator Name
Florian Krismer
Principal Investigator Email
mui-oversight@i-med.ac.at
Contact Person Name
Florian Krismer
Contact Person Email
mui-oversight@i-med.ac.at

France

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
555
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurology
Principal Investigator Name
Jean-Christophe CORVOL
Principal Investigator Email
jean-christophe.corvol@aphp.fr
Contact Person Name
Jean-Christophe CORVOL
Contact Person Email
jean-christophe.corvol@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Neurology
Principal Investigator Name
Olivier RASCOL
Principal Investigator Email
rascol@cict.fr
Contact Person Name
Olivier RASCOL
Contact Person Email
rascol@cict.fr
Site Name
Hospices Civils De Lyon
Department Name
Neurology
Principal Investigator Name
Stéphane THOBOIS
Principal Investigator Email
stephane.thobois@chu-lyon.fr
Contact Person Name
Stéphane THOBOIS
Contact Person Email
stephane.thobois@chu-lyon.fr

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
ION464

Related trials

Other published trials that may interest you.