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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2026-03-06

No results posted yet for this 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

Interventions

DRUG

placebo

Subjects will take matching placebo for 12 months followed by a 6-month open-label extension phase.

DRUG

MN-166

Subjects will take MN-166 for 12 months followed by a 6-month open-label extension phase.

Sponsors & Collaborators

  • MediciNova

    lead INDUSTRY

Principal Investigators

  • Project Management Team · Medicinova Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2027-04-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057898 on ClinicalTrials.gov