Clinical Trial Search

Primary: Daily Muscle Cramps — 6.1; 4.7; 4.9; 2.5 Cramps per 24 hours

Primary: Visual Analog Scale (MCS-VAS) Score — 2.07; 1.7 score 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: Number of Participants With a Decrease in Cramp Duration — 2; 0 participants

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

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

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

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

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: Electrical Impedance Myography — 0.55 Coefficient of Variation

Primary: Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC) — -6.46; -4.97; -4.62; -4.58 percent predicted — p=0.1095

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

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: 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: Dose Limiting Toxicities (DLT) — 1; 2 Participants

Primary: Change in ALS Functional Rating Scale - Revised (ALSFRS-R) — -0.905; -0.983; -0.743 scores on a scale

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 (ALSFRS-R) — -1.00; -1.26 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 — -5.7; -6.35 units on a scale

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

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

Primary: Change in Frequency of Leg Cramps — .99; .53 Cramps per week

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

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

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

Primary: Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone — 1719 ng·h/mL

Primary: Number of Participants With Safe, Well-tolerated Moderate Intensity Respiratory Muscle Training (RMT) as Measured by Rating of Perceived Exertion (RPE) — 4 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