Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04454840 | Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis | EARLY_PHASE1 | COMPLETED | 20 | — | — | May 1, 2016 | May 1, 2019 | Jul 7, 2020 | 1 | China |
Rate of amyotrophic lateral sclerosis Functional Rating Scale scores changes
| Arm | Type | Description |
|---|---|---|
| Biological+Riluzole | EXPERIMENTAL | Plasma from healthy young people treatment + Riluzole |
| Riluzole | ACTIVE_COMPARATOR | Riluzole |
| Name | Type | Description |
|---|---|---|
| Plasma from healthy young people treatment + Riluzole | BIOLOGICAL | Intravenous injection: the subjects received 400ml of intravenous plasma infusion every 2 weeks, with a continuous course of 2 treatments and a course of treatment every 3 months. The course of treatment lasted 10 months, with a total of 3200ml of plasma infusion. |
| Riluzole | DRUG | The basic treatment is Riluzole 25\~50mg twice daily |
Inclusion Criteria: * Meet the following diagnosis standard: confirmed, proposed and laboratory supported diagnosis; * Age 50-70 years old ; * 3-18 months course of disease; * Forced vital capacity (FVC) ≥70% predicted value; * Total amyotrophic lateral sclerosis Functional Rating Scale score ≥36, ...