Sporadic Amyotrophic Lateral Sclerosis
Conditions
Brief summary
ALS Functional Rating Scale - Revised – self-explenatory (ALSFRS-R-SE) change from baseline (first dose of study drug) to 79 weeks after administration of the first dose compared to standard therapy riluzole alone
Detailed description
ALSFRS-R-SE change from baseline to 3, 27, 53, 105 and 131 weeks, Change in the slow vital capacity score (pulmonary fuction test) from baseline to 79 weeks, Change of BMI from baseline to 79 weeks, Tracheostomy-free survival at 79 weeks, Overall survival in Rituximab and standard therapy group, Laboratory parameters evaluating the safety of treatment with Rituximab, Serum and cerebrospinal fluid analyses with cell count, cytology, protein, glucose, lactate and infection markers, B cell counts, Neuropsychological tests (ECAS), Quality of Life questionnaire
Interventions
DRUGIsotonische Kochsalzlösung Fresenius Infusionslösung
DRUGParacetamol B. Braun 10 mg/ml Infusionslösung
Sponsors
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALS Functional Rating Scale - Revised – self-explenatory (ALSFRS-R-SE) change from baseline (first dose of study drug) to 79 weeks after administration of the first dose compared to standard therapy riluzole alone | — |
Secondary
| Measure | Time frame |
|---|---|
| ALSFRS-R-SE change from baseline to 3, 27, 53, 105 and 131 weeks, Change in the slow vital capacity score (pulmonary fuction test) from baseline to 79 weeks, Change of BMI from baseline to 79 weeks, Tracheostomy-free survival at 79 weeks, Overall survival in Rituximab and standard therapy group, Laboratory parameters evaluating the safety of treatment with Rituximab, Serum and cerebrospinal fluid analyses with cell count, cytology, protein, glucose, lactate and infection markers, B cell counts, Neuropsychological tests (ECAS), Quality of Life questionnaire | — |
Countries
Germany
Outcome results
None listed