New ALS drug safety trial launches for Long-Term study
NCT ID NCT07571174
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This study tests the long-term safety of a drug called LY4256984, given via spinal injection, in people with ALS. It includes 32 participants who completed an earlier study and will be followed for about 96 weeks. The main goal is to see how many people have serious side effects related to the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY4256984 (a drug given via spinal injection)
- What this could lead to
- If successful, this could show that LY4256984 is safe enough to continue testing as a potential treatment to slow ALS progression.
- What could go wrong
- This is a very early (Phase 1) study with only 32 participants. It focuses on safety, not effectiveness, so it may not lead to a working treatment. Spinal injections carry risks like back pain or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Participants must meet eligibility criteria in the \[L0U-MC-OLMP\] screening protocol before entry into the treatment study. Inclusion Criteria: * Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA. Exclusion Criteria: * The participant has conditions that preclude a lumbar puncture (LP), such as: * A history of clinically significant back pain, back pathology, and/or back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP. * Allergy to local anesthetics, such as lidocaine or its derivatives. * A local infection at the intended site of the LP. * Less than 100 giga per liter \[(\<100 GI/L) is equivalent to 100,000 per cubic millimeter (100,000/mm³)\] platelets or clinically significant coagulation abnormality or significant active bleeding, or * Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Universitari de Bellvitge
NOT_YET_RECRUITINGL'Hospitalet de Llobregat, 08907, Spain
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Hospital Universitari i Politecnic La Fe
NOT_YET_RECRUITINGValencia, 46026, Spain
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McGill University Health Centre
RECRUITINGMontreal, H4A 3J1, Canada
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Sunnybrook Research Institute
RECRUITINGToronto, M4N 3M5, Canada
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UZ Leuven
NOT_YET_RECRUITINGLeuven, 3000, Belgium
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Universitaetsklinikum Ulm
NOT_YET_RECRUITINGUlm, 89081, Germany
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Universitair Medisch Centrum Utrecht
NOT_YET_RECRUITINGUtrecht, 3584 CX, Netherlands
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University Hospital - London Health Sciences Centre
NOT_YET_RECRUITINGLondon, N6A 5A5, Canada
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Universitätsklinikum Schleswig-Holstein
NOT_YET_RECRUITINGLübeck, 23538, Germany
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Universitätsmedizin Rostock
NOT_YET_RECRUITINGRostock, 18147, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Breathing device tested to slow lung decline in ALS
- Can hospital codes reliably track home ventilation in ALS?
- Can a synthetic compound be safe enough to test in ALS? early trial asks
- Can a cheap gout drug slow ALS? trial puts colchicine to the test
- Can donor gut bacteria reshape the immune system in ALS?
- Spinal injection drug targets genetic cause of ALS and dementia