A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY4256984.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Canada, Germany, Netherlands, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug LY4256984
Administered IT
Primary outcome measures
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Time frame: Baseline Up to Week 96]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Canada · 3 centers
- University Hospital - London Health Sciences Centre — London
- McGill University Health Centre — Montreal
- Sunnybrook Research Institute — Toronto
Germany · 3 centers
- Universitätsklinikum Schleswig-Holstein — Lübeck
- Universitätsmedizin Rostock — Rostock
- Universitaetsklinikum Ulm — Ulm
Spain · 2 centers
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
- Hospital Universitari i Politecnic La Fe — Valencia
Belgium · 1 center
- UZ Leuven — Leuven
Netherlands · 1 center
- Universitair Medisch Centrum Utrecht — Utrecht
Identifiers
NCT: NCT07571174 · 27887 · L0U-MC-OL01 · L0U-MC-OLMP · 2026-525574-19-00