NCT03876262

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

A Randomized, Double Blind, Parallel Trial in the Democratic Republic of Congo (DRC) Comparing the Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Treatment of Onchocerciasis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Medicines Development for Global Health · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Onchocerciasis

Interventions

Type	Name	Description
DRUG	Moxidectin	2mg tablets, encapsulated for blinding
DRUG	Ivermectin	3mg tablets, encapsulated for blinding

Timeline

• Start date: 2021-05-03
• Primary completion: 2024-07-31
• Completion: 2026-01-01
• First posted: 2019-03-15
• Last updated: 2025-12-23

Locations

1 site across 1 country: Democratic Republic of the Congo

Regulatory

• FDA-regulated drug study