Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
Public ClinicalTrials.gov record NCT04057898. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04057898
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 234 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 28, 2020 (Actual)
- Primary completion
- Apr 2027 (Estimated)
- Completion
- Apr 2028 (Estimated)
- Last update posted
- Mar 6, 2026
2020 – 2028
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California | Orange | California | 92868 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Indiana University IU Health Neuroscience Center | Indianapolis | Indiana | 46202 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Hennepin Healthcare Research Institute | Minneapolis | Minnesota | 55415 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04057898, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 6, 2026 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04057898 live on ClinicalTrials.gov.