Clinical trial • Phase I • Neurology|Rare Disease
LY4256984 for Sporadic Amyotrophic Lateral Sclerosis | Amyotrophic lateral sclerosis
Phase I trial of LY4256984 for Sporadic Amyotrophic Lateral Sclerosis | Amyotrophic lateral sclerosis. None/Not specified-controlled. 30 participants.
Overview
- Trial Therapeutic Area
- Neurology|Rare Disease
- Trial Disease
- Sporadic Amyotrophic Lateral Sclerosis | Amyotrophic lateral sclerosis
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 22-05-2025
- First CTIS Authorization Date
- 02-09-2025
Trial design
None/Not specified-controlled Phase I trial across 7 sites in Netherlands, Spain, Belgium and others.
- Comparator
- None/Not specified
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 30
Eligibility
Recruits 30 Vulnerable population selected; no details provided on consent or assent handling..
- Vulnerable Population
- Vulnerable population selected; no details provided on consent or assent handling.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 26
- Consent Approach
- Vulnerable population selected; no details provided on consent or assent process or languages; consent/assent approach not described in provided data.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 30
Netherlands
- Earliest CTIS Part Ii Submission Date
- 06-06-2025
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 178
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Neurology
- Contact Person Name
- Leonard van den Berg
- Contact Person Email
- l.h.vandenberg@umcutrecht.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 08-07-2025
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 146
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurologist
- Contact Person Name
- Juan Francisco Vázquez Costa
- Contact Person Email
- vazquez_juacos@gva.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Neurologist
- Contact Person Name
- Mónica Povedano Panadés
- Contact Person Email
- mpovedano@bellvitgehospital.cat
Belgium
- Earliest CTIS Part Ii Submission Date
- 06-08-2025
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 114
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- UZ Leuven
- Department Name
- Neurology
- Contact Person Name
- Philip Van Damme
- Contact Person Email
- philip.vandamme@uzleuven.be
Germany
- Earliest CTIS Part Ii Submission Date
- 06-06-2025
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 178
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Campus Luebeck / Präzisionsneurologie Haus D1
- Contact Person Name
- Julian Großkreutz
- Contact Person Email
- julian.grosskreutz@uni-luebeck.de
- Site Name
- Rostock University Medical Center
- Department Name
- Klinik und Poliklinik für Neurologie /Sektion für Translationale Neurodegeneration Albrecht Kossel
- Contact Person Name
- Andreas Hermann
- Contact Person Email
- Andreas.hermann@med.uni-rostock.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Studienzentrum Neurologie
- Contact Person Name
- Jochen Weishaupt
- Contact Person Email
- Jochen.weishaupt@rku.de
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- LY4256984
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