Clinical Trial Search

Primary: Number of Participants With Response — 0 participants

Primary: Death — 134 participants

Primary: Number of Participants Who Had Any Serious Adverse Events or Any Adverse Events With Severity Higher Than "Moderate". — 0; 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: Percentage of Participants With Cervical Intraepithelial Neoplasia III (CIN III) — 10.93; 10.25; 10.84 percentage of participants

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: Number of Participants With Serious AEs, TEAEs That Lead to Premature Discontinuation, Abnormal Laboratory Test Results, Abnormal ECG Readings. — 0; 0; 0; 0 Participants

Primary: Progression-free Survival (PFS) — 24.016; 11.072; 16.821 months — p=<0.0001

Primary: Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery — 38; 44; 78 participants — p=0.3416

Primary: Neonatal Composite Outcome — 165; 202; 145; 184 Participants — p=0.02

Primary: Percentage of Patients Free From Lead, Delivery System and Implant Related Complications. — 82.2 percentage of patients

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

Primary: Disease Progression as Assessed by the ALSFRS-R Total Score — -1.11; -1.03 ALSFRS-R total score points per month

Primary: Change From Baseline to Endpoint (Week 13/Early Termination) in Pruritus — -1.470; -1.486; -0.620; -0.580 Score on a scale — p=0.0321

Primary: Histological Lesion Clearance — 61.5; 38.5 percentage of complete clearance — p=0.375

Primary: Overall Survival — 14.9; 11.3 Months — p=0.00005

Primary: Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment — 33; 45 percentage of participants — p=0.038

Primary: Safety of Allopurinol — 55.1 percentage of subjects

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: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 23; 24; 2; 2 Participants

Primary: Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) — 11.5; 11.8; 8.6; 8.7 scores on a scale

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

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

Primary: Disease Progression as Assessed by the ALSFRS-R-Slope — -1.00; -0.91; -0.95 Points per month

Primary: Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) — 0; 0; 5; 2 Participants

Primary: Growth Rate of GA Lesions, as Assessed by Fundus Autofluorescence (FAF) — 1.62; 1.87 mm2/year

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

Primary: Disease Progression as Assessed by the ALSFRS-R Total Score — -0.99; -1.00 points per month

Primary: Disease-Free Survival (DFS) at the Primary Analysis — 1.9; 1.3; 1.0; 1.5 Years — p=0.048

Primary: Number of Participants With Cardiac Response and Non-Response — 26; 30; 40; 33 Participants — p=0.3190