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NCT04057898 · ClinicalTrials.gov record · last posted 2026-03-06

Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS

Study acronym: COMBAT-ALS
StatusActive, Not Recruiting
PhasePhase 2/3
SponsorMediciNova
Started2020-05-28
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 54 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 54 times since 2019-08-13; most recent amendment 2026-03-04. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-09-15
Status change Recruiting→Active, Not Recruitingv53
2020-05-28
Status change Not Yet Recruiting→Recruitingv3
Trial Details
NCT Number NCT04057898
Lead Sponsor MediciNova
Conditions Amyotrophic Lateral Sclerosis
Enrollment 234 participants
Start Date 2020-05-28
Primary Completion 2027-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-06