Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onchocerciasis
Lead sponsor: Medicines Development for Global Health
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 12997
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 (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.

Primary outcomes:
measure: Incidence and severity of treatment emergent adverse events
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rethy
country: Congo, The Democratic Republic of the
facility: Centre de Recherche pour les Maladies Tropicales Negligees
state: Ituri
city: Abidjan
country: Côte D'Ivoire
facility: Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
Study officials:
affiliation: Centre de Recherche en Maladies Tropicales de l'Ituri
name: Tony Ukety, MD, DO, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
name: Benjamin Koudou, PhD
role: PRINCIPAL_INVESTIGATOR
References: