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

Onchocerciasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04311671
• Other study ID #: MDGH-MOX-3002
• Status: Recruiting
• Phase: Phase 3
• Start date: May 3, 2021
• Est. completion date: July 2024

Study information

• Verified date: June 2023
• Source: Medicines Development for Global Health
• Contact: Sally Kinrade
• Phone: +61 3 9912 2411
• Email: sally.kinrade[@]medicinesdevelopment.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12500
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Filariasis
• Onchocerciasis

Intervention

Drug:
• Moxidectin
2 mg tablets, encapsulated for blinding
• Ivermectin
3 mg tablets, encapsulated for blinding
• Albendazole
400 mg tablets

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Centre de Recherche pour les Maladies Tropicales Negligees	Rethy	Ituri
Côte D'Ivoire	Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire	Abidjan

Sponsors (1)

Lead Sponsor	Collaborator
Medicines Development for Global Health

Countries where clinical trial is conducted

Congo, The Democratic Republic of the,  Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3 months