Clinical Trial Search

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

Primary: Death — 134 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: Combined Assessment of Function and Survival (CAFS) — 0.51; 0.49 score on a scale — p=0.6208

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

Primary: Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 18 — 45.3; 29.5 percentage of participants

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

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

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

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

Primary: Change From Baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score After 48 Weeks. — -11.2; -10.8 units on a scale

Primary: Neurologic Impairment Score + 7 (NIS+7) — 8.2; 26.3; 6.2; 12.5 units on a scale — p=<0.001

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

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

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

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

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

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

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

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

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

Primary: The Proportion of Responder Patients in the Two Treatment Groups According the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)-R Slope. — 13; 6 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: Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] — 10…

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