Clinical Trial Search

Primary: Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month — 0 Participants

Primary: Change in Percent of Expected Lung Force Vital Capacity — -1.25 % Expected Forced Vital Capacity

Primary: Death — 134 participants

Primary: Change in Revised ALS Functional Rating Scale (ALSFRS-R) — 0.44 points per month — p=0.99

Primary: Rate of Change in Composite Manual Muscle Testing (MMT) Score — 0.44; 0.39 MMT units per month — p=0.529

Primary: The Primary Comparison for Efficacy Will be Based on a Linear Mixed Effects (LME) Model Fit to the ALSFRS-R Data for the Patients Followed Over 36 Weeks. — -0.290…

Primary: Safety and Tolerability of MN-166 60 mg/d Versus Placebo When Administered With Riluzole in Subjects With ALS — 17; 34; 8; 11 Participants

Primary: ALS Functional Rating Scale-Revised (ALSFRS-R) — -1.00; -1.26 score on a scale

Primary: Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) — -1.0; -1.5; -4.0; -5.5 units on a scale — p=<0.0001

Primary: Respiratory Complications Severity — 8.33; 9.0; 7.8 score on a scale

Primary: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks — -5.5; -4.2; -5.4 units on a scale

Primary: Accuracy of Typing With a BCI Keyboard by ALS Patients. — 81; 78; 75 percentage accuracy

Primary: Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) — -1.20; -0.94 units on a scale — p=0.07

Primary: Number of Participants Who Had Any Serious Adverse Events or Any Adverse Events With Severity Higher Than "Moderate". — 0; 0 Participants

Primary: Change in Monthly Rate of Decline in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score - Revised) — 1.20; 1.01 points per month

Primary: ALS Functional Rating Scale-revised Version (ALSFRS-R) Slope — -0.39; -0.57 points per month — p=0.32

Primary: Change From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Score — 39.8; -1.3; -2.5; -5.0 units on scale

Primary: Combined Assessment of Function and Survival (CAFS) — 0.51; 0.49 score on a scale — p=0.6208

Primary: Safety as Measured by the Number of Participants Experiencing Adverse Events — 16 Participants

Primary: Number of Patients Tolerant to Study Drug — 6; 12 Participants — p=0.602

Primary: Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R) — -1.05; -1.00 Units on a Scale per Month — p=0.4807

Primary: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Slope Change — -1.66; -1.24 Change in ALSFRS-R Total Score Per Month — p=0.03

Primary: Visual Analog Scale (MCS-VAS) Score — 2.07; 1.7 score on a scale

Primary: Change in Revised ALS Functioning Rating Scale (ALSFRS-R) — -1; -7.1; -3.2; -7.1 Change score on ALSFRS-R

Primary: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks — -5.01; -7.5 units on a scale

Primary: Safety and Tolerability — 8; 8; 10; 16 participants

Primary: Safety Outcomes: Frequency of Adverse Events — 49; 24; 42 Total Number of Adverse Events — p=0.06

Primary: Pharmacodynamic Biomarkers: MCP-1 On-treatment Period Variation — 4.6; 2.2 pg/ml — p=0.6346

Primary: Number of Participants With Serious Adverse Events as Measured by Patient Reporting — 2 Participants

Primary: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks — -6.52; -6 units on a scale