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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04311671
Other study ID # MDGH-MOX-3002
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 3, 2021
Est. completion date September 2024

Study information

Verified date June 2024
Source Medicines Development for Global Health
Contact n/a
Is FDA regulated No
Health authority
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 Active, not recruiting
Enrollment 12997
Est. completion date September 2024
Est. primary completion date September 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.

Study Design


Related Conditions & MeSH terms


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
See also
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