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
- Calgary, London, Montreal, and Toronto, CanadaSee the 4 sites
- Phase
- Phase 1
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 Canada
- Heritage Medical Research ClinicCalgary, CanadaNot yet recruiting
- University Hospital - London Health Sciences CentreLondon, CanadaNot yet recruiting
- McGill University Health CentreMontreal, CanadaTaking people
- Sunnybrook Research InstituteToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.