Clinical Trial: Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

The primary purpose of this study is to determine the safety and tolerability of moxidectin in subjects infected with O. volvulus with special emphasis on Mazzotti reactions to determine whether it is safe enough to expose a number of subjects sufficient for obtaining statistically significant data on the safety and efficacy of moxidectin relative to ivermectin.

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.


Detailed Summary:
Sponsor: World Health Organization

Current Primary Outcome: Incidence of clinical adverse events and clinically significant laboratory test results [ Time Frame: Duration of follow up (18 months) ]

Original Primary Outcome: Incidence of clinical adverse events and clinically significant laboratory test results

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Skin mf counts at day 8 and months 1, 2, 3, 6 and 12
  • Nodulectomy at 18 months
  • PK at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12


Information By: World Health Organization

Dates:
Date Received: March 7, 2006
Date Started: September 2006
Date Completion:
Last Updated: February 13, 2012
Last Verified: February 2012