NCT00300768

Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

A Randomized, Single-Ascending Dose, Ivermectin-Controlled, Double-Blind, Safety, Tolerability, Pharmacokinetic, and Efficacy Study Of Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Medicines Development for Global Health · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study was to determine the safety and tolerability of moxidectin in subjects infected with Onchocerca volvulus (a parasitic worm).

Detailed description

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.

Conditions

• Onchocerciasis

Interventions

Type	Name	Description
DRUG	2 mg moxidectin	Single-dose, tablet encapsulated for blinding
DRUG	ivermectin 150 mcg/kg	Single-dose, tablets encapsulated for blinding
DRUG	4 mg moxidectin	Single dose, tablets encapsulated for blinding
DRUG	8 mg moxidectin	single dose, tablets encapsulated for blinding

Timeline

• Start date: 2006-09-06
• Primary completion: 2009-11-01
• Completion: 2009-11-29
• First posted: 2006-03-09
• Last updated: 2022-12-15

Locations

1 site across 1 country: Ghana