Centre de Recherche pour les Maladies Tropicales Negligees
Rethy, Ituri, Democratic Republic of the Congo
NCT Number: NCT03876262
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.
This study is active but is not currently recruiting participants.
Notify Me12 year and older
All sexes
Interventional
Phase 3
Rethy, Ituri, Democratic Republic of the Congo
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2mg tablets, encapsulated for blinding
3mg tablets, encapsulated for blinding
Time frame: Up to 12 months
Proportion of recipients with zero Onchocerca volvulus microfilariae/mg skin at all post-treatment timepoints to month 12
Time frame: Up to 36 months
Incidence and severity of adverse events, vital signs and liver function tests
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Proportion of participants with 0 live O. volvulus microfilariae in the anterior chambers of the eyes at all post-Baseline assessments in those with liver ocular microfilariae before the first treatment
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Mean, median and percentage reduction Onchocerca volvulus microfilariae/mg skin from baseline
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Proportion of participants in all dose groups with 0 Onchocerca volvulus microfilariae/mg skin and 0 live microfilariae in the anterior chambers of the eyes each timepoint
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Mean and mean change from baseline of Onchocerca volvulus microfilariae/mg skin
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Proportion of participants with signs and symptoms of onchocerciasis with these signs and symptoms at baseline.
Time frame: 36 months
Histopathological assessment of male and female macrofilariae excised from participants with palpable nodules
Medicines Development for Global Health
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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