Skip to main content
OpenTrials
Completed

NCT Number: NCT04311671

Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole

The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire, Abidjan, Côte d’Ivoire

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of written informed consent, or assent with parental or guardian written consent*
  • Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin (participants ≥12 years of age only).
  • Living in an onchocerciasis endemic area.
  • Age ≥4 years
  • All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3). * Expression of 'deliberate objection' will be the basis for assessing assent of children aged ≥ 4 to <6 years

Exclusion criteria

  • Pregnant or breast-feeding.
  • Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health.
  • Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline.
  • Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
  • Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high levels of LF co-endemicity, known or suspected allergy to albendazole and its excipients.
  • Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations.
  • Infection with Loa loa.
  • Height <90 cm.

Treatment and study plan

Moxidectin

Drug

2 mg tablets, encapsulated for blinding

Ivermectin

Drug

3 mg tablets, encapsulated for blinding

Albendazole

Drug

400 mg tablets

Primary outcomes

  1. Incidence and Severity of Treatment Emergent Adverse Events

    Time frame: Up to 3 months

    Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis.

Sponsors and collaborators

Lead sponsor

Medicines Development for Global Health

Other

Registry information

Official study title

A Randomized, Double Blind, Parallel Group Clinical Trial to Evaluate the Safety of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Treatment With Albendazole

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2020
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.