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 an Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis
Status: Not yet recruiting
Phase of Trial: Phase II/III
Latest Information Update: 30 Aug 2019
Price : $35 *
At a glance
- Drugs Ibudilast (Primary)
- Indications Amyotrophic lateral sclerosis
- Focus Registrational; Therapeutic Use
- Sponsors MediciNova
- 13 Aug 2019 Status changed from planning to not yet recruiting.
- 05 Jun 2019 According to a MediciNova media release, the company held a kick-off meeting for the official launch of this trial. The company expects to initiate patient enrollment shortly.
- 15 Apr 2019 According to a MediciNova media release, the U.S. FDA has completed its review of the protocol and determined that the company may proceed with a Phase 2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS). If this potentially pivotal trial is successful, the Phase 2b/3 efficacy and safety data is intended to support a New Drug Application (NDA) for MN-166 (ibudilast) in ALS.