Clinical Trial Search

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

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

Primary: Death — 134 participants

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

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

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

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

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: 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: Number of Participants With Serious Adverse Events as Measured by Patient Reporting — 2 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: Accuracy of Typing With a BCI Keyboard by ALS Patients. — 81; 78; 75 percentage accuracy

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

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

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

Primary: The Change From Baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) Total Score to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind…

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

Primary: Mean Change in SOD1 CSF — 6.8 ng/ml

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

Primary: Joint Rank Scores for Combined Analysis of Function (Amyotrophic Lateral Sclerosis Functional Rating Scale Revised [ALSFRS-R] Score) and 48 Week Overall Survival — 15.0…

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: Number of Subjects With Serious and Non Serious Adverse Events — 1; 1; 1; 1 Participants

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: 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: Bulbar Function Scale (CNS-BFS) Total Score — 53.45; 59.31 units on a scale — p=0.0003

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: Acceptance Rate of Early Non-invasive Positive Pressure Ventilation (NIPPV) Treatment. — 0; 23; 35 Participants

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