drugset / Trial / NCT07660614

A Study of LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis

NCT07660614 ↗

Phase 1/2 Recruiting 56 enrolled Leal Therapeutics, Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will examine what happens when patients with amyotrophic lateral sclerosis (ALS) are given an investigational medication (study drug) known as LTX-002. Specifically, the researchers will be looking at safety, tolerability (if someone has any side effects from the drug), pharmacokinetics (what the body does to the study drug) and pharmacodynamics (what the study drug does to the body). The study will also investigate the effect of the drug on indicators of the severity of ALS, such as markers in blood and in the cerebrospinal fluid (the fluid that surrounds the brain and spinal cord, CSF) and on measures of the participant's ability to move, speak, and breathe.

Timeline

Start
2026-04-29
Primary completion
2031-06
Completion
2031-06

Drugs

EvaluationDrugModalityDoseRoute
Subject LTX-002 Antisense oligonucleotide — Intrathecal