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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 15 May 2025

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At a glance

  • Drugs Ibudilast (Primary) ; Riluzole
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms COMBAT-ALS
  • Sponsors MediciNova

Most Recent Events

  • 05 Dec 2024 According to a MediciNova media release, as of mid-November 2024, over 200 patients have been enrolled and more than 180 patients assigned, if the company continue to actively enroll in the COMBAT-ALS study, the company expect to complete patient assignments by June 2025 with trial results expected in 2026.
  • 05 Dec 2024 Interim analysis results from this trial presented in the MediciNova Media Release
  • 23 Oct 2024 According to a MediciNova media release, an update (scientific rationale, study objectives, study design, major inclusion criteria and enrollment update as of Oct 18, 2024) of this ongoing Phase 2/3 clinical trial of MN-166 (ibudilast) in ALS patients presented at the 2024 Annual NEALS Meeting being held virtually on Oct 21-24, 2024.

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