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Taking peoplePhase 1

Long-term safety of LY4256984 given into the spinal fluid in people with sporadic ALS

Follows long-term safety of LY4256984 in adults with sporadic amyotrophic lateral sclerosis.

Plain-language title generated from the registry record
Registry title: A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

Key facts

Where
Leuven, BelgiumSee the site
Phase
Phase 1

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with sporadic amyotrophic lateral sclerosis (ALS) who finished the earlier study J6I-MC-OWAA. It checks long-term safety of LY4256984 given into the spinal fluid.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
Sporadic amyotrophic lateral sclerosis (ALS).
Earlier treatment
People must have finished the main treatment period and any off-treatment period of Study OWAA.

Main reasons for not taking part

  • Conditions that rule out a lumbar puncture
  • Back pain, back disease or back injury that could cause problems with a lumbar puncture
  • Allergy to local anesthetics such as lidocaine
  • Infection at the lumbar puncture site
  • Fewer than 100 giga per liter platelets, a clotting problem, or blood-thinning treatment (low-dose aspirin is allowed)

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Source: NCT07571174, who can take part

Where in Belgium

  • UZ LeuvenLeuven, BelgiumContact: Philip Van Damme (principal investigator)Not yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Eli Lilly and Company
Trial code
NCT07571174
Record updated
22 September 2026
Original description
The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.Read full original descriptionShow less

A Study of Long-Term Safety, Tolerability, and Clinical Outcomes of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis: A Multicenter, Open-Label, Long-Term Extension of Study J6I-MC-OWAA

The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.

Inclusion: 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: 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.

Participants must meet eligibility criteria in the [L0U-MC-OLMP] screening protocol before entry into the treatment study.

ClinicalTrials.gov NCT07571174