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

NCT ID: NCT03876262

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Onchocerciasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to four groups: annual ivermectin; annual moxidectin; biannual ivermectin; or biannual moxidectin
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Annual Ivermectin

Ivermectin (approximately) 150 micrograms/kg per oral, administered annually for 24 months

Group Type ACTIVE_COMPARATOR

Ivermectin

Intervention Type DRUG

3mg tablets, encapsulated for blinding

Biannual Ivermectin

Ivermectin (approximately) 150 micrograms/kg per oral, administered biannually for 24 months

Group Type EXPERIMENTAL

Ivermectin

Intervention Type DRUG

3mg tablets, encapsulated for blinding

Annual Moxidectin

Moxidectin 8mg per oral, administered annually for 24 months

Group Type EXPERIMENTAL

Moxidectin

Intervention Type DRUG

2mg tablets, encapsulated for blinding

Biannual Moxidectin

Moxidectin 8mg per oral, administered biannually for 24 months

Group Type EXPERIMENTAL

Moxidectin

Intervention Type DRUG

2mg tablets, encapsulated for blinding

Interventions

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Moxidectin

2mg tablets, encapsulated for blinding

Intervention Type DRUG

Ivermectin

3mg tablets, encapsulated for blinding

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of written informed consent, or assent with parental or guardian written consent.
* Mean ≥ 10 O. volvulus microfilariae/mg skin, determined by four skin snips
* Living in a village selected for the study.
* Age ≥ 12 years.
* All female participants of childbearing potential must commit to the use of a reliable method of birth control for the duration of treatment and until 3 months after completion of dosing with investigational product.

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, oral diethylcarbamazine (DEC) or doxycycline (for \> 2 weeks) within 6 months of Baseline.
* Has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer) prior to Baseline.
* Known or suspected allergy to ivermectin or moxidectin or their excipients.
* Self-reported planned or ongoing activities within the study period that would make it unlikely that a participant will be available for all planned treatment rounds and follow-up examinations.
* Weight \> 88 kg.
* Infection with Loa loa.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medicines Development for Global Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tony Ukety, MD, DO, MPH

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche en Maladies Tropicales de l'Ituri

Locations

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Centre de Recherche pour les Maladies Tropicales Negligees

Rethy, Ituri, Democratic Republic of the Congo

Site Status

Countries

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Democratic Republic of the Congo

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MDGH-MOX-3001

Identifier Type: -

Identifier Source: org_study_id