December 21, 2022
Moxidectin for river blindness: clinical study updates
- Paediatric dose-finding study [MDGH-MOX-1006; NCT03962062]: Study completed. Data from this study will be used in support of an application to the United States Food and Drug Administration for inclusion of children in the approved label and future approvals by other national regulatory agencies.
- Repeat dose study [MDGH-MOX-3001; NCT03876262]: Medicines Development for Global Health received endorsement from the United States Food and Drug Administration for a proposed protocol revision to reduce the total number of participants to be included in the study from 1000 to 320. The milestone of seventy-five percent of n=320 participants recruited to that study was also reached.
- Single-dose endemic community safety study [MDGH-MOX-3002; NCT04311671]: The study protocol is being amended to reflect the addition of a second trial site, in Côte d’Ivoire.