Long-term safety of a new treatment for ALS given through the spine

Plain-English translation of NCT07571174 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This is a follow-up study testing the long-term safety of , a new medication given through injections into the spinal fluid for people with ALS. Researchers want to make sure this medication remains safe and well-tolerated over time in people who completed an earlier study. This trial will last approximately 96 weeks (about 2 years).

Early testing showed that this medication might be helpful for ALS, but researchers need to understand how safe it is when people continue to receive it over many months. This longer-term study helps doctors learn whether this treatment is safe enough to potentially help more patients.

Do you qualify?

You likely qualify if…

you successfully completed the earlier treatment study (Study OWAA) and any follow-up period after it ended
you have been diagnosed with sporadic ALS (the most common form of the disease)
you are willing to receive injections into your spinal fluid every few weeks for the duration of the study

You likely don't qualify if…

you have a history of serious back problems, back surgery, or spinal deformity that could make spinal injections difficult or unsafe
you are allergic to local anesthetics like lidocaine
you are currently taking blood thinners or medications that affect bleeding or clotting
you have an active infection at the injection site or have very low platelet counts or bleeding problems

What participation looks like

As a participant, you would continue to receive the medication through injections into your spinal fluid, similar to what you received in the earlier study. You'll have regular visits over about 96 weeks where doctors will monitor your safety through physical exams, blood tests, and check-ins about how you're feeling. The main goal is to make sure the medication continues to be safe and doesn't cause unexpected problems over time.

AI-generated summary from trial data · Jul 1, 2026 · Not medical advice

Trial locations(10 sites)

Belgium

UZ Leuven, Leuven

Canada

University Hospital - London Health Sciences Centre, London

McGill University Health Centre, Montreal

Sunnybrook Research Institute, Toronto

Germany

Universitätsklinikum Schleswig-Holstein, Lübeck