ALS drug safety check: new study tests Long-Term effects
NCT ID NCT07571200
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 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 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Amyotrophic lateral sclerosis are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
10 sites in 5 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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_RECRUITINGL'Hospitalet de Llobregat, 08907, Spain
-
Hospital Universitari i Politecnic La Fe
NOT_YET_RECRUITINGValencia, 46026, Spain
-
McGill University Health Centre
RECRUITINGMontreal, H4A 3J1, Canada
-
Sunnybrook Research Institute
RECRUITINGToronto, M4N 3M5, Canada
-
UZ Leuven
NOT_YET_RECRUITINGLeuven, 3000, Belgium
-
Universitaetsklinikum Ulm
NOT_YET_RECRUITINGUlm, 89081, Germany
-
Universitair Medisch Centrum Utrecht
NOT_YET_RECRUITINGUtrecht, 3584 CX, Netherlands
-
University Hospital - London Health Sciences Centre
NOT_YET_RECRUITINGLondon, N6A 5A5, Canada
-
Universitätsklinikum Schleswig-Holstein
NOT_YET_RECRUITINGLübeck, 23538, Germany
-
Universitätsmedizin Rostock
NOT_YET_RECRUITINGRostock, 18147, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to dozens of diseases
- Can a NAD-Boosting supplement slow ALS? extension trial tests nicotinamide riboside and pterostilbene
- Breathing support in ALS: what it means for patients and families
- Virtual reality and robots put to the test in neuromuscular rehab
- Breathing device tested to slow lung decline in ALS
- Can hospital codes reliably track home ventilation in ALS?