An Open-label, Adaptive Design Study in Patients With Amyotrophic Lateral Sclerosis (ALS) to Characterize Safety, Tolerability and Brain Microglia Response, as Measured by TSPO Binding, Following Multiple Doses of BLZ945 Using Positron Emission Tomography
Study Purpose:
It is an open label study to evaluate safety, tolerability and brain microglia response in ALS patients following multiple doses of BLZ945.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
EnrollingPhase:
Phase IIStudy Chair(s)/Principal Investigator(s):
Clinicaltrials.gov ID (11 digit #):
NCT04066244Neals Affiliated?
NoCoordinating Center Contact Information
Novartis Pharmaceuticals / .(JavaScript must be enabled to view this email address) / 1-888-669-6682
.(JavaScript must be enabled to view this email address) United States
Full Study Summary:
The purpose of the study is to identify a dose (or doses) of BLZ945, that measurably decrease(s) TSPO binding in the brain of ALS subjects, and to evaluate the safety and tolerability of BLZ945 in ALS subjects 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 ALS subjects will be assessed at different times post dosing.