Clinical Trials Logo
  1. Home
  2. Onchocerciasis
  3. NCT00300768

Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

Onchocerciasis Clinical Trial

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 Volvulus Infection

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00300768
Study type Interventional
Source Medicines Development for Global Health
Contact
Status Completed
Phase Phase 2
Start date September 6, 2006
Completion date November 29, 2009
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04035174 - Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa N/A
Recruiting NCT03653975 - Clinical Features and Potential Etiology of Epilepsy and Nodding Syndrome in the Mahenge Area, Ulanga District
Completed NCT03052998 - Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy Phase 4
Recruiting NCT04311671 - Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole Phase 3
Active, not recruiting NCT03876262 - Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis Phase 3
Terminated NCT04913610 - Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-4083 Capsules When Given Alone or In Combination With Albendazole Capsules Moves in The Body of Adult Participants With Onchocerca Volvulus Infection Phase 2
Completed NCT03962062 - A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years Phase 1
Completed NCT01905436 - Mass Drug Administration for Lymphatic Filariasis and Onchocerciasis for Liberia
Recruiting NCT00001230 - Host Response to Infection and Treatment in Filarial Diseases
Completed NCT05750043 - Effect of Onchocerciasis Elimination Measures on the Incidence of Epilepsy in Maridi, South Sudan
Completed NCT05749653 - Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area N/A
Completed NCT02078024 - Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana Phase 3
Completed NCT00127504 - Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness Phase 2
Completed NCT03131401 - Prevalence of LF Infection in Districts Not Included in LF Control Activities
Not yet recruiting NCT06070116 - Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis Phase 2
Completed NCT02032043 - Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast (DOLF-Ivory Coast)
Completed NCT04188301 - Safety and Efficacy of IDA for Onchocerciasis Phase 2
Terminated NCT05084560 - Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug Phase 1
Completed NCT03517462 - Ocular Changes After Ivermectin - (DOLF IVM/Oncho) N/A
Active, not recruiting NCT05180461 - Emodepside Phase II Trial for Treatment of Onchocerciasis Phase 2