Clinical trial • Phase I • Neurology
Prosetin for Amyotrophic lateral sclerosis
Phase I trial of Prosetin for Amyotrophic lateral sclerosis. Randomised, placebo (dose/schedule not specified)-controlled, adaptive. 26 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Amyotrophic lateral sclerosis
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 11-10-2023
- First CTIS Authorization Date
- 05-02-2024
Trial design
Randomised, placebo (dose/schedule not specified)-controlled, adaptive Phase I trial across 1 site in Netherlands.
- Randomised
- Yes
- Comparator
- Placebo (dose/schedule not specified)
- Adaptive
- True, Dose-escalating design with single ascending and multiple ascending dose cohorts; details of escalation rules not specified
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 26
Recruitment
- Planned Sample Size
- 26
- Recruitment Window Months
- 45
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 26
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-01-2024
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 778
- Number Of Sites
- 1
- Number Of Participants
- 14
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Neurology & Neurosurgery
- Principal Investigator Name
- L.H. Van den Berg
- Principal Investigator Email
- L.H.vandenBerg@umcutrecht.nl
- Contact Person Name
- L.H. Van den Berg
- Contact Person Email
- L.H.vandenBerg@umcutrecht.nl
Sponsor
Primary sponsor
- Full Name
- Projenx Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Prosetin
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