Table of contents
- Trial overview
- Who can participate
- How the study is run
- What is being measured
- Study status and size
- Patient glossary
Trial overview
The available study for LTX-002 SODIUM is an interventional clinical trial in adults with amyotrophic lateral sclerosis (ALS).[1] It is designed to evaluate the safety and effects of LTX-002 SODIUM when it is given in the spinal canal, and it compares the study treatment with placebo.[1]
The study is in Phase 1/2, which means it is an early-stage trial that looks at safety and also at early signs of benefit.[1] The source describes the study as authorised.[1]
Who can participate
The trial is for adult participants with ALS.[1] The source data does not list full entry rules such as age limits beyond adulthood, disease stage, or other health requirements.[1]
This means the study team would need to check whether a person fits the study rules before enrollment.[1]
How the study is run
LTX-002 SODIUM is given by intrathecal administration, which means it is delivered into the intrathecal space in the spinal canal.[1] The spinal canal is the space in the spine that surrounds the spinal cord and contains spinal fluid.[1]
The comparison treatment is placebo, which is made to look like the study medicine but does not contain an active substance.[1] In this trial, the placebo is a corresponding volume of sterile aCSF solution formulation intended for intrathecal use.[1]
What is being measured
The main goal is to check safety and tolerability, meaning how well participants can receive the study treatment without major problems.[1]
The primary outcomes include the incidence and severity of adverse events, treatment-emergent adverse events, and serious adverse events.[1] These are medical problems that happen during the study, including problems that start after treatment begins and problems that are severe enough to be considered serious.[1]
The study also measures clinical laboratory tests, including serum chemistry, hematology, and urinalysis.[1] These tests check blood and urine for signs of health changes during the trial.[1]
Other measurements include ECGs, vital signs, and physical and neurological exams.[1] ECGs record the heart’s electrical activity, vital signs include blood pressure, heart rate, breathing rate, and body temperature, and neurological exams check how the nervous system is working.[1]
Study status and size
The study is listed as authorised and has an enrollment target of 56 participants.[1] This is a relatively small trial, which is common in early research stages when safety is being studied first.[1]
The trial is interventional, so participants are assigned to receive a study treatment or placebo as part of the research plan.[1]
Patient glossary
- ALS: a disease that affects nerve cells and can lead to muscle weakness and loss of movement.[1]
- Placebo: a look-alike treatment with no active substance, used for comparison.[1]
- Intrathecal: given into the space around the spinal cord.[1]
- Phase 1/2: an early study phase that focuses on safety and early signs of effect.[1]
- Serum chemistry: blood tests that look at chemicals in the blood to help check organ function.[1]
- Hematology: blood tests that check blood cells and related health information.[1]
- Urinalysis: a urine test that can show signs of health changes.[1]
- Neurological exam: a check of how the brain, nerves, and muscles are working.[1]
