Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS (NCT04057898)
A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis
🩺 Plain-English Summary (8th-Grade Level)
A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase.
Who can join: Review the eligibility criteria below.
Location: University of California — Orange, California
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- University of California — Orange, California
- Mayo Clinic — Jacksonville, Florida
- Augusta University — Augusta, Georgia
- Indiana University IU Health Neuroscience Center — Indianapolis, Indiana
- Johns Hopkins University — Baltimore, Maryland
- Hennepin Healthcare Research Institute — Minneapolis, Minnesota
- SUNY Upstate Medical University — Syracuse, New York
- Duke University — Durham, North Carolina
- Lehigh Valley Health Network — Allentown, Pennsylvania
- University of Virginia Health System — Charlottesville, Virginia
- University of Alberta Hospital — Edmonton, Alberta
- McMaster University Medical Center — Hamilton, Ontario
- Sunnybrook Research Institute — Toronto, Ontario
- Montreal Neurological Institute and Hospital — Montreal, Quebec
- University of Saskatchewan - Sastakoon Hospital — Saskatoon, Saskatchwean
- Hopital de L'Enfant-Jesus, CHU de Quebec-Universite Laval — Québec,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Amyotrophic Lateral Sclerosis
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- Regulatory T Cells for Amyotrophic Lateral Sclerosis — New York, New York
- Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL) — Phoenix, Arizona
- TRIAL READY (Clinical Trial Readiness) — Miami, Florida
- Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment — Phoenix, Arizona
- Personalized Antisense Oligonucleotide for a Single Participant With CHCHD10 ALS — New York, New York
Explore by condition: All Amyotrophic Lateral Sclerosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.