Clinical Trial Search

Primary: Death — 134 participants

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

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: Change in Muscle Strength From Baseline — 74.7; 74.7; 76.4; 74.5 units on a scale — p==0.001

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

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: Mean Change in SOD1 CSF — 6.8 ng/ml

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

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

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

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

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 of Intramuscular Injections of Engensis in Participants With Amyotrophic Lateral Sclerosis Compared to Placebo — 4; 3; 3; 1 Participants

Primary: Percentage of Participants That Discontinued Study Drug — 5; 32; 5 percentage of participants

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

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

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

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

Primary: Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication — 2; 0; 2; 0 Participants

Primary: Count of Adverse Events Reported — 109; 52 adverse events reported

Primary: ALSFRS-R Total Score at Weeks 0, 2, 4 and 8 — 38.60; 38.60; 38.15; 38.29 scores on a scale — p=0.780

Primary: Change in ALSFRS-R Slope — 0.229; 0.224 ALSFRS-R points per week — p=0.984

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: Change in Resting Motor Threshold — -2.430; 0.805; 4.746; 1.465 percentage of maximum stimulus output — p=0.039

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: 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

Primary: Duration of Day Time Wear Time of the Device — 718.536; 730.882; 653.980; 207.263 Minutes

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

Primary: Parts A and B: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) — 2; 2; 3; 3 Participants

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