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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

Testing MN-166 (Ibudilast) in ALS patients for 18 months.

Recruiting
18-80 years
All
Phase 2/3

The study is to test a drug called MN-166 (Ibudilast) for people with ALS, a disease that affects the nerves and muscles. **ALS** stands for Amyotrophic Lateral Sclerosis, which causes muscle weakness and difficulty speaking, swallowing, and breathing. The study will last for 18 months. The first 12 months are a "double-blind" phase, meaning neither patients nor doctors know if they're receiving MN-166 or a placebo (a pill with no medicine). After that, patients can join a 6-month "open-label" phase where everyone knows they're getting MN-166.

To join, you must be between 18 and 80 years old, have had ALS for 18 months or less, and meet other health criteria. You cannot join if you have certain health issues, like liver problems or severe psychiatric disorders, or if you've been in another study recently.

  • **Study Duration:** 18 months total (12 months double-blind, 6 months open-label)
  • **Eligibility:** Must be 18-80 years old with ALS diagnosed within the last 18 months
  • **Requirements:** Must not have severe liver issues or certain psychiatric disorders
Study details
    Amyotrophic Lateral Sclerosis

NCT04057898

MediciNova

10 May 2025

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