A Phase 2 interventional study of 2 mg moxidectin and ivermectin 150 mcg/kg in Onchocerciasis, sponsored by Medicines Development for Global Health. Completed at 1 site in Ghana. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-12-15.
Sponsored by Medicines Development for Global Health · Phase 2, Interventional, and Treatment
The primary purpose of this study was to determine the safety and tolerability of moxidectin in subjects infected with Onchocerca volvulus (a parasitic worm).
This was a phase 2, randomized, ivermectin-controlled, double-blind, single-ascending-dose, parallel design, inpatient/outpatient study of moxidectin administered to subjects of both sexes with different degrees of severity of O. volvulus infection. The study was conducted at a single site in Ghana.
Secondary objects are to determine the pharmacokinetics of moxidectin, to obtain initial indication of the efficacy in terms of long term effect on skin microfilaria levels and an indication of the effect on the macrofilaria that may underlie the effect on skin microfilaria levels.
Subjects were enrolled in consecutive cohorts to receive a single oral dose of 2 mg, 4 mg or 8 mg or moxidectin or ivermectin 150 µg/kg by severity of infection, based on the mean of the skin microfilariae densities at each of 4 body locations, both iliac crests and calves.
34 studies on the registry are indexed under Onchocerciasis; 6 are open to participants now.
This study's enrollment of 172 is below the median of 264 across 24 interventional studies indexed under Onchocerciasis.
Browse Onchocerciasis studies →Medicines Development for Global Health is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 mg moxidectin (Dose-escalation 1st step)
Drug: 2 mg moxidectin
Active comparator arm (ivermectin 150 mcg/kg).
Drug: ivermectin 150 mcg/kg
4 mg moxidectin (dose escalation second step)
Drug: 4 mg moxidectin
8 mg moxidectin (dose escalation third step)
Drug: 8 mg moxidectin
Single-dose, tablet encapsulated for blinding
Single-dose, tablets encapsulated for blinding
Single dose, tablets encapsulated for blinding
single dose, tablets encapsulated for blinding
Incidence of clinical adverse events and clinically significant laboratory test results
Time frame: Duration of follow up (18 months)
Skin mf counts at day 8 and months 1, 2, 3, 6, 12 and 18
Time frame: day 8 and months 1, 2, 3, 6, 12, 18
Nodulectomy at 18 months
Time frame: 18 months
Pharmacokinetics (PKs) at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12
Time frame: days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Medicines Development for Global Health