Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04057898 · ClinicalTrials.gov registry record · Phase 2
Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
A Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by MediciNova.
- Active
- Registry status
- Phase 2
- Development phase
- 234
- Enrollment target
- 16
- Study locations
NCT04057898: Active Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by MediciNova.
NCT04057898 is a Phase 2 study of Amyotrophic Lateral Sclerosis that is active but no longer recruiting, run by MediciNova. The registered enrollment target is 234 participants, below the 896-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (74% lower). The trial reports 16 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04057898, a Phase 2 study of Amyotrophic Lateral Sclerosis, is active but no longer recruiting, sponsored by MediciNova.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 234 participants
- Enrollment target
- 16
- Study locations
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.
Primary Outcome
The amyotrophic lateral sclerosis functional rating scale-revised, or ALSFRS-R, measures the functional status of subjects with ALS. It is based on 12 items, each of which is rated on a 5-point scale (0 to 4). The rate of total functional disability thus ranges from 0 (maximum disability) to 48 (normal function) points.
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 |
What the registry record for NCT04057898 still lists
NCT04057898 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, below the 896-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (74% lower).
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.
NCT04057898 lists 16 locations in 15 states (Ontario, California, Florida).
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.
What interventions are being tested in trial NCT04057898?
The interventions under investigation include: placebo (DRUG), MN-166 (DRUG).
Who is sponsoring clinical trial NCT04057898?
This trial is sponsored by MediciNova, which has 17 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04057898's enrollment target sits among peer trials
234 28th of 102 higher than 75 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
RECRUITING · Phase 2
-
HEALEY ALS Platform Trial - Master Protocol
RECRUITING · Phase 2
-
RAPA-501 Therapy for ALS
RECRUITING · Phase 2
-
A Study of Ranolazine in ALS
RECRUITING · Phase 2
-
Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL)
ACTIVE NOT RECRUITING · Phase 2
-
Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04942717 · 234 participants · NA
Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values
- NCT05208671 · 234 participants · NA
Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
- NCT05444465 · 234 participants · NA
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
- NCT05720338 · 234 participants · Phase 3
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI