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Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
NCT04057898 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG placebo
- DRUG MN-166
Study Locations (16)
Ontario
- McMaster University Medical Center — Hamilton
- Sunnybrook Research Institute — Toronto
California
- University of California — Orange
Florida
- Mayo Clinic — Jacksonville
Georgia
- Augusta University — Augusta
Indiana
- Indiana University IU Health Neuroscience Center — Indianapolis
Maryland
- Johns Hopkins University — Baltimore
Minnesota
- Hennepin Healthcare Research Institute — Minneapolis
New York
- SUNY Upstate Medical University — Syracuse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2028-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04057898
The ClinicalTrials.gov registry entry for NCT04057898 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 234 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MediciNova, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04057898 reports 16 study locations spanning 15 distinct geographic areas — top geographies include Ontario, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04057898 about?
NCT04057898 is a clinical study titled "Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS". 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.
What is the current status of trial NCT04057898?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 234 participants. The study started on 2020-05-28. Estimated completion is 2028-04.
What conditions does trial NCT04057898 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04057898?
The interventions under investigation include: placebo (DRUG), MN-166 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04057898?
This trial is sponsored by MediciNova, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04057898 being conducted?
This trial has 16 study locations across California, Florida, Georgia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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