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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
172
Single-dose, tablet encapsulated for blinding
Single-dose, tablets encapsulated for blinding
Single dose, tablets encapsulated for blinding
Onchocerciasis Chemotherapy Research Center
Hohoe, Volta Region, Ghana
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
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single dose, tablets encapsulated for blinding