Expanded access to ibudilast for ALS patients through a networked care program
Official title: Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS (SEA-NOBI-ALS)
Funded at Mayo Clinic Jacksonville · NIH-11415507 · Data updated 2026-11-12
ALS patients could gain access to the experimental drug ibudilast through a coordinated program that connects doctors, home visits, and easy online consent and monitoring.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Mayo Clinic Jacksonville NIH-funded |
| Lab location | 1 site (Jacksonville, United States) |
| Project start | September 1, 2024 |
| Project end | August 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $5,728,540 |
| NIH project number | 5U01NS136022-03 |
| Project ID | NIH-11415507 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults with ALS who are eligible for expanded access and can be enrolled through the Mayo Clinic Jacksonville network.
✕Less likely to help
Patients not eligible for expanded access or those who experience contraindications or lack of access to the network may not benefit.
What this research studies
This program offers ALS patients access to ibudilast outside traditional trials, using a Mayo Clinic–led network to enroll up to 200 participants over six months. It uses streamlined e-consent, home-health interactions, and centralized safety and outcomes tracking to reduce participation burden. Patients can receive the study drug through physicians’ offices or their homes, with safety overseen by clinicians. The approach aims to keep care practical and patient-friendly while collecting important safety data.
Why it matters
Potential benefit: Participants may access a promising therapy sooner and contribute to safety and outcome information that could guide ALS care.
How similar studies have gone: Expanded access programs have previously provided access to experimental ALS therapies and have shown feasibility in coordinating care and data collection.
Where this research is happening
-
Mayo Clinic Jacksonville
Jacksonville, United States Active
Researchers
- Principal investigator: Oskarsson, Bjorn E — Mayo Clinic Jacksonville
- Study coordinator: Oskarsson, Bjorn E
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.