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New ALS drug safety trial launches for Long-Term study

NCT ID NCT07571174

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hospital Universitari de Bellvitge

    NOT_YET_RECRUITING

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital Universitari i Politecnic La Fe

    NOT_YET_RECRUITING

    Valencia, 46026, Spain

  • McGill University Health Centre

    RECRUITING

    Montreal, H4A 3J1, Canada

  • Sunnybrook Research Institute

    RECRUITING

    Toronto, M4N 3M5, Canada

  • UZ Leuven

    NOT_YET_RECRUITING

    Leuven, 3000, Belgium

  • Universitaetsklinikum Ulm

    NOT_YET_RECRUITING

    Ulm, 89081, Germany

  • Universitair Medisch Centrum Utrecht

    NOT_YET_RECRUITING

    Utrecht, 3584 CX, Netherlands

  • University Hospital - London Health Sciences Centre

    NOT_YET_RECRUITING

    London, N6A 5A5, Canada

  • Universitätsklinikum Schleswig-Holstein

    NOT_YET_RECRUITING

    Lübeck, 23538, Germany

  • Universitätsmedizin Rostock

    NOT_YET_RECRUITING

    Rostock, 18147, Germany

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