Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04057898 | Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS | PHASE2 | ACTIVE NOT_RECRUITING | 234 | — | — | May 28, 2020 | Apr 1, 2028 | Mar 6, 2026 | 16 | United States, Canada |
| NCT02238626 | Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS) | PHASE2 | COMPLETED | 70 | — | — | Sep 1, 2014 | Dec 1, 2017 | Nov 5, 2021 | 1 | United States |
The amyotrophic lateral sclerosis functional rating scale-revised, or ALSFRS-R, measures the functional status of subjects with ALS. It is based on 12 items, each of which is rated on a 5-point scale (0 to 4). The rate of total functional disability thus ranges from 0 (maximum disability) to 48 (normal function) points.
Safety will be assessed by monitoring and recording all treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs and Additional assessments will include regular monitoring of hematology, blood chemistry, and urine values, regular measurement of vital signs, ECGs, medical history, physical and neurological examinations.
| Arm | Type | Description |
|---|---|---|
| MN-166 | EXPERIMENTAL | Subjects will take MN-166 10 mg capsules, up to 50 mg twice a day for 12 months. |
| placebo | PLACEBO_COMPARATOR | Subjects will take up to 5 matching placebo capsules twice a day for 12 months. |
| Placebo (for MN-166) | PLACEBO_COMPARATOR | Sugar pill manufactured for MN-166 10 mg tablets plus 50 mg riluzole by mouth twice daily for 6 months. |
| Name | Type | Description |
|---|---|---|
| MN-166 | DRUG | Subjects will take MN-166 for 12 months followed by a 6-month open-label extension phase. |
| placebo | DRUG | Subjects will take matching placebo for 12 months followed by a 6-month open-label extension phase. |
| Placebo (for MN-166) | DRUG | - |
| riluzole | DRUG | Patient is given 50 mg riluzole twice daily. |
Major Inclusion Criteria: * Male or female subjects age 18 - 80 years, inclusive; * Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS \[clinically definite, clinically probable, probable-laboratory-supported\]; * ALS onset of ≤18...