drugset / Trial / NCT03876262

Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis

NCT03876262

Phase 3 Active not recruiting 323 enrolled Medicines Development for Global Health
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O. volvulus microfilaria in skin, the parasite that causes river blindness. Secondary purposes are to determine the effectiveness of moxidectin compared to ivermectin once or twice a year in maintaining undetectable levels, or reducing levels, of skin microfilaria.

Timeline

Start
2021-05-03
Primary completion
2024-07-31
Completion
2026-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivermectin Small molecule 150 ug/kg Oral
Subject Moxidectin Other / unclassified 8 mg Oral

Indications