drugset / Trial / NCT07193953
Intravenous Immunoglobulin (IVIG) and Blood-Brain Barrier Disruption in Amyotrophic Lateral Sclerosis (ALS)
Phase 1
Active not recruiting
6 enrolled
Sunnybrook Health Sciences Centre
Focused Ultrasound Foundation · collab
NaSequentialOpen-labelTreatment
Summary
The goal of this study is to evaluate the safety and feasibility of IVIg administration in conjunction with primary motor cortex BBB opening using the Next Generation Dome Helmet (NGDH) FUS in adult participants with ALS.
Timeline
- Start
- 2025-04-15
- Primary completion
- 2026-11-30
- Completion
- 2027-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.2 g/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.4 g/kg | Intravenous |