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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202003567524647

Enrollment

12500

Registered

2020-03-19

Start date

2021-02-15

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onchocerciasis

Interventions

Moxidectin

Ivermectin

Moxidectin with concomitant albendazole

Ivermectin with concomitant albendazole

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provision of written informed consent, or assent with parental or guardian written consent. 2. Known O. volvulus skin microfilariae density =0 microfilariae/mg skin 3. Living in an onchocerciasis endemic area. 4. Age = 4 years. 5. 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).

Exclusion criteria

Exclusion criteria: 1. Pregnant or breast-feeding. 2. 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. 3. Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline. 4. Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration. 5. Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high LF co-endemicity requiring concomitant albendazole administration,known or suspected allergy to albendazole and its excipients 6. 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. 7. Infection with Loa loa

Design outcomes

Primary

Measure	Time frame
Incidence and severity of treatment emergent adverse events. 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.	—

Measure

Time frame

Incidence and severity of treatment emergent adverse events. 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.

—

Countries

Cote Divoire, Democratic Republic of the Congo

Contacts

Public ContactSally Kinrade

Moxidectin for Onchocerciasis Project Leader

sally.kinrade@medicinesdevelopment.com+61399122400

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026