Expanded access to ibudilast for people with ALS with biomarker testing
Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS (SEA-NOBI-ALS)
This program offers ibudilast to people with ALS for six months and includes blood biomarker checks such as neurofilament.
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 ID | NIH-11178598 on NIH RePORTER |
What this research studies
You would be offered ibudilast through an expanded-access program for up to 200 people with ALS. Mayo Clinic and WideTrial will run a network of ALS physicians with streamlined e-consent, enrollment, home-health visit ordering, drug delivery, and safety oversight so most visits can be done at home or virtually. The program lasts six months of treatment with regular virtual or in-office check-ins to monitor safety and symptoms. Blood and other samples will be collected to measure neurofilament and other biomarkers to learn how the drug affects ALS biology.
Who could benefit from this research
Good fit: Adults diagnosed with ALS who are willing to take ibudilast for six months and participate in remote or clinic monitoring are the intended candidates.
Not a fit: People with medical contraindications to ibudilast, those unable to comply with monitoring or visits, or those seeking a guaranteed cure may not receive benefit from participation.
Why it matters
Potential benefit: This could provide access to a promising medicine for people with ALS and produce biomarker data that may help guide future care.
How similar studies have performed: Ibudilast has an established safety record and is currently in a phase 2/3 trial for ALS, but clear proof of clinical benefit in ALS has not yet been demonstrated.
Where this research is happening
Jacksonville, United States
- 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 below.