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| ID | Type | Description | Link |
|---|---|---|---|
| L0U-MC-OL01 | Other Identifier | Eli Lilly and Company | |
| L0U-MC-OLMP | Other Identifier | Eli Lilly and Company | |
| 2026-525574-19-00 | Other Identifier | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4256984 | Experimental | LY4256984 administered intrathecally (IT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4256984 | Drug | Administered IT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Participants must meet eligibility criteria in the [L0U-MC-OLMP] screening protocol before entry into the treatment study.
Inclusion Criteria:
Exclusion Criteria:
The participant has conditions that preclude a lumbar puncture (LP), such as:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | 3176154559 | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Not yet recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| McGill University Health Centre | Recruiting | Montreal | H4A 3J1 | Canada |
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| Sunnybrook Research Institute | Not yet recruiting | Toronto | M4N 3M5 | Canada |
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| Universitätsklinikum Schleswig-Holstein | Not yet recruiting | Lübeck | 23538 | Germany |
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| Universitätsmedizin Rostock | Not yet recruiting | Rostock | 18147 | Germany |
|
| Universitaetsklinikum Ulm | Not yet recruiting | Ulm | 89081 | Germany |
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| Universitair Medisch Centrum Utrecht | Not yet recruiting | Utrecht | 3584 CX | Netherlands |
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| Hospital Universitari de Bellvitge | Not yet recruiting | L'Hospitalet de Llobregat | 08907 | Spain |
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| Hospital Universitari i Politecnic La Fe | Not yet recruiting | Valencia | 46026 | Spain |
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| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |