drugset / Trial / NCT03508453
IC14 for Treatment of Amyotrophic Lateral Sclerosis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Fifty patients with amyotrophic lateral sclerosis that is progressing rapidly will be randomized to receive either the monoclonal antibody IC14 or placebo to be given intravenously over two hours twice weekly for 12 weeks. Blood and urine tests will be done to measure biomarkers in order to evaluate clinical response and to monitor for safety. Other evaluations include patient questionnaires about function, quality of life and mental function; pulmonary function test; and sniff nasal pressure.
Timeline
- Start
- 2021-08-15
- Primary completion
- 2023-05-15
- Completion
- 2023-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | IC14 | Monoclonal antibody | 4 mg/kg | Intravenous |