Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
A Phase 1/2, Multicenter, Three-part Study to Evaluate the Safety, Tolerability, and Efficacy of Intrathecally Administered Gene Therapy AMT-162 in Patients With SOD1 Amyotrophic Lateral Sclerosis (SOD1-ALS).
This is the study of AMT-162 in rapidly progressive ALS Patients with SOD1 Mutations and is designed to evaluate the Safety, Tolerability, and Efficacy of Intrathecally Administered Gene Therapy AMT-162. AMT-162-001 is a Phase 1/2, Multi-center, Three-part Study : Part I Single Ascending Dose, Part II Randomized, Double-blind, Placebo-controlled, and Part III Extended Follow-up.
AMT-162 is an investigational gene therapy that encodes an artificial micro-ribonucleic acid (microRNA or miRNA) targeting the SOD1 gene. This clinical study will test the safety of AMT-162 and explore the hypothesis that it will silence expression of mutant cytosolic SOD1 and thereby ameliorate the course of ALS cause by this mutant gene. ;
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