Study of Safety and of the Mechanism of BLZ945 in ALS Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Amyotrophic Lateral Sclerosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: This study is an exploratory, adaptive, open-label study of multiple oral doses of BLZ945 in participants with ALS.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The purpose of the study is to identify a dose (or doses) of BLZ945, that measurably decrease(s) TSPO binding in the brain of participants with ALS, and to evaluate the safety and tolerability of BLZ945 in participants with ALS at these doses and dosing regimen. PET imaging with a ligand selective f...
The purpose of the study is to identify a dose (or doses) of BLZ945, that measurably decrease(s) TSPO binding in the brain of participants with ALS, and to evaluate the safety and tolerability of BLZ945 in participants with ALS at these doses and dosing regimen. PET imaging with a ligand selective for TSPO is widely used as a marker for microglial activation. Following microglia reduction, the repopulation of microglia in participants with ALS will be assessed at different times post dosing.
Tracking Information
- NCT #
- NCT04066244
- Collaborators
- Not Provided
- Investigators
- Not Provided
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