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ALS drug safety check: new study tests Long-Term effects

NCT ID NCT07571200

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This study looks at the long-term safety of an experimental drug called LY4256984 for people with ALS. It enrolls up to 32 participants who have completed a prior ALS trial. The study will follow them for at least 96 weeks to see how well the drug is tolerated over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY4256984
What this could lead to
If successful, this could help confirm that these experimental drugs are safe enough to use in larger trials for ALS.
What could go wrong
This is a very early (Phase 1) study with only 32 people. It focuses on safety, not effectiveness, so it may not lead to a treatment.

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 below. Additional criteria are specified in the substudy to which the participant will enroll. Inclusion Criteria: * Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS. * Note 1: To be considered a "completer" of a parent study, the participant must finish the main treatment period/phase of the parent study as well as any off-treatment period/phase as described in the parent study's protocol. * Note 2: Visits missed in a parent study will have no impact on the completer status of a potential participant. Exclusion Criteria: * During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator. * During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator. * During the parent study, the participant developed an unresolved SAE or a medical illness (other than ALS) that, in the opinion of the investigator, precludes either continued exposure to an IMP or participation in study procedures due to an unacceptable risk to the participant's safety.

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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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