A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
ConditionAmyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEli Lilly and Company
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
LY4256984
DrugAdministered IT
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: LY4256984Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 96Sponsors and contacts
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Source ClinicalTrials.gov