Clinical trial

A Randomized, Double Blind, Parallel Trial in the Democratic Republic of Congo (DRC) Comparing the Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Treatment of Onchocerciasis

Name
MDGH-MOX-3001
Description
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.
Trial arms
Trial start
2021-05-03
Estimated PCD
2024-07-01
Trial end
2026-07-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Moxidectin
2mg tablets, encapsulated for blinding
Arms:
Annual Moxidectin, Biannual Moxidectin
Ivermectin
3mg tablets, encapsulated for blinding
Arms:
Annual Ivermectin, Biannual Ivermectin
Size
323
Primary endpoint
Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12
Up to 12 months
Incidence and severity of adverse events
Up to 36 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be assigned to four groups: annual ivermectin; annual moxidectin; biannual ivermectin; or biannual moxidectin', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 323, 'type': 'ACTUAL'}}
Updated at
2023-08-04

1 organization

2 products

1 indication

Product
Moxidectin
Indication
Onchocerciasis
Product
Ivermectin