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NCT00790998 Clinical Trial

Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

Onchocerciasis Clinical Trial

Official title:
A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00790998
Other study ID # 3110A1-3000
Secondary ID B1751006 - ONCBL
Status Completed
Phase Phase 3
First received November 13, 2008
Last updated January 29, 2018
Start date April 2009
Est. completion date May 2012

Study information
Verified date November 2013
Source Medicines Development Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.

Recruitment information / eligibility
Status Completed
Enrollment 1497
Est. completion date May 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria:

- Pregnant or breast feeding women; coincidental loiasis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Moxidectin
Single dose of moxidectin 2 mg oral tablet x 4
• Ivermectin
Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4

Locations
Country Name City State
Congo, The Democratic Republic of the Centre de Recherche Clinique de Butembo - Université Catholique du Graben Butembo
Congo, The Democratic Republic of the Centre de Recherche en Maladies Tropicales de l'Ituri Rethy
Ghana Onchocerciasis Chemotherapy Research Center Hohoe
Liberia Liberian Institute for Biomedical Research Clinical Research Center Bolahun Lofa County

Sponsors (2)
Lead Sponsor Collaborator
Medicines Development Limited World Health Organization

Countries where clinical trial is conducted

Congo, The Democratic Republic of the,  Ghana,  Liberia, 

References & Publications (1)

Opoku NO, Bakajika DK, Kanza EM, Howard H, Mambandu GL, Nyathirombo A, Nigo MM, Kasonia K, Masembe SL, Mumbere M, Kataliko K, Larbelee JP, Kpawor M, Bolay KM, Bolay F, Attah SK, Vaillant M, Halleux CM, Kuesel AC. Single dose moxidectin versus ivermectin f — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary skin microfilaria density (mf/mg) 12 months
Secondary skin microfilaria density (mf/mg) 1 month
Secondary skin microfilaria density (mf/mg) 6 months
Secondary skin microfilaria density (mf/mg) 18 months
Secondary skin microfilaria reduction from baseline 1 month
Secondary skin microfilaria reduction from baseline 6 months
Secondary skin microfilaria reduction from baseline 12 months
Secondary skin microfilaria reduction from baseline 18 months
Secondary proportion of subjects with undetectable levels of skin microfilaria 1 month
Secondary proportion of subjects with undetectable levels of skin microfilaria 6 months
Secondary proportion of subjects with undetectable levels of skin microfilaria 12 months
Secondary proportion of subjects with undetectable levels of skin microfilaria 18 months
Secondary percent reduction in microfilaria levels in the anterior chamber of the eye 12 months
See also
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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

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