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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — Baseline Up to Week 96
Trial sites (11)
Facility
City
Region
Status
UZ Leuven
Leuven
Belgium
Not Yet Recruiting
Heritage Medical Research Clinic
Calgary
Canada
Not Yet Recruiting
University Hospital - London Health Sciences Centre
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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