Clinical trial • Phase I • Neurology

Clinical trial in Stroke

Phase I trial for Stroke. 144 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Stroke
Trial Stage
Phase I
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
07-10-2024
First CTIS Authorization Date
05-11-2024

Trial design

Phase I trial across 6 sites in France.

Target Sample Size
144

Eligibility

Recruits 144 Vulnerable population selected; no details on consent or assent handling available in provided documents..

Vulnerable Population
Vulnerable population selected; no details on consent or assent handling available in provided documents.

Recruitment

Planned Sample Size
144
Recruitment Window Months
96

Geography

Total Number Of Sites
6
Total Number Of Participants
144

France

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
20-03-2025
Processing Time Days
143
Number Of Sites
6
Number Of Participants
144

Sites

Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Urgences Cérébro-Vasculaires
Contact Person Name
Charlotte ROSSO
Contact Person Email
charlotte.rosso@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Neurovasculaire
Contact Person Name
Igor SIBON
Contact Person Email
igor.sibon@chu-grenoble.fr
Site Name
CHU de Besançon
Department Name
Neurovasculaire
Contact Person Name
Louise BONNET
Contact Person Email
l1bonnet@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Neurologie Vasculaire
Contact Person Name
Lucie DELLA SCHIAVA
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Neurovasculaire
Contact Person Name
Olivier DETANTE
Contact Person Email
odetante@chu-grenoble.fr
Site Name
GHU St Anne Psychiatrie et Neurosciences
Department Name
Neurovasculaire
Contact Person Name
David CALVET
Contact Person Email
d.calvet@ghu-paris.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire Grenoble Alpes
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

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