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| ID | Type | Description | Link |
|---|---|---|---|
| L0U-MC-OLMP | Other Identifier | Eli Lilly and Company | |
| L0U-MC-OL01 | Other Identifier | Eli Lilly and Company | |
| 2026-525574-19-00 | Other Identifier | EU Trial (CTIS) Number] |
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Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174). The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that will last at least 96 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4256984 | Experimental | OL01 Substudy: LY4256984 administered intrathecally (IT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4256984 | Drug | Administered IT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA) | Baseline Up to Week 96 |
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Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll.
Inclusion Criteria:
Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS.
Exclusion Criteria:
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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 | 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 |
|
| Universitätsklinikum Schleswig-Holstein | Not yet recruiting | Lübeck | 23538 | Germany |
|
| 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 |