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New drug moxidectin put to the test against river blindness in massive safety trial

NCT ID NCT04311671

Disease control Sponsor: Medicines Development for Global Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large Phase 3 trial compared the safety of a single dose of moxidectin versus ivermectin in nearly 13,000 people living in areas where river blindness is common. Some participants also received albendazole for lymphatic filariasis. The goal was to see if moxidectin causes fewer or less severe side effects. Results will help determine if moxidectin can be a safer alternative for controlling this parasitic disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
moxidectin (compared to ivermectin, with or without albendazole)
What this could lead to
If moxidectin proves safer, it could become a new treatment option for river blindness, potentially reducing side effects in affected communities.
What could go wrong
This trial only measures safety, not effectiveness. Even if safe, moxidectin may not work better than existing treatments. Results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

12,979 people

The number who actually took part.

Started

May 2021

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (participants ≥12 years of age only). 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). \* Expression of 'deliberate objection' will be the basis for assessing assent of children aged ≥ 4 to \<6 years 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 levels of LF co-endemicity, 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. 8. Height \<90 cm.

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Conditions

The condition(s) this trial relates to.

onchocerciasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Onchocerciasis

Contacts and locations

Locations

  • Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire

    Abidjan, Côte d’Ivoire

  • Centre de Recherche pour les Maladies Tropicales Negligees

    Rethy, Ituri, Democratic Republic of the Congo

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