Access to a promising drug for ALS patients
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-11040273 · Data updated 2026-11-12
This study is offering ALS patients a chance to try ibudilast, a drug being tested for their condition, even if they can't join a clinical trial, and they'll be able to receive it for six months while being monitored, either in person or from home.
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 | 2024 |
| Award (this year) | $6,133,297 |
| NIH project number | 1U01NS136022-01A1 |
| Project ID | NIH-11040273 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are individuals diagnosed with amyotrophic lateral sclerosis (ALS) who are seeking new treatment options.
✕Less likely to help
Patients who are not diagnosed with ALS or those who do not meet the specific eligibility criteria for the expanded access program may not benefit from this research.
What this research studies
This research aims to provide access to ibudilast, a drug currently in clinical trials for ALS, through an expanded access program. It addresses the challenge that many ALS patients face in accessing experimental therapies due to strict trial criteria. The program will enroll 200 ALS patients for a six-month period, allowing them to receive ibudilast while being monitored for safety and effectiveness. Patients will have the option to participate in evaluations either in-person at a physician's office or virtually from home, making it more convenient for them.
Why it matters
Potential benefit: If successful, this research could provide ALS patients with access to a potentially effective treatment that is currently not widely available.
How similar studies have gone: Other research has shown success with expanded access programs for experimental therapies, indicating that this approach could be beneficial for ALS patients as well.
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
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.