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

NCT03876262 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2025-12-23

No results posted yet for this study

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

DRUG

Moxidectin

2mg tablets, encapsulated for blinding

DRUG

Ivermectin

3mg tablets, encapsulated for blinding

Sponsors & Collaborators

  • Medicines Development for Global Health

    lead OTHER

Principal Investigators

  • Tony Ukety, MD, DO, MPH · Centre de Recherche en Maladies Tropicales de l'Ituri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2024-07-31
Completion
2026-01-01
FDA Drug
Yes

Countries

  • Democratic Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876262 on ClinicalTrials.gov