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Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

Primary Purpose

Onchocerciasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Moxidectin
Ivermectin
Sponsored by
Medicines Development for Global Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onchocerciasis focused on measuring onchocerciasis, river blindness, onchocerca volvulus, moxidectin, ivermectin

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria:

  • Pregnant or breast feeding women; coincidental loiasis

Sites / Locations

  • Centre de Recherche Clinique de Butembo - Université Catholique du Graben
  • Centre de Recherche en Maladies Tropicales de l'Ituri
  • Onchocerciasis Chemotherapy Research Center
  • Liberian Institute for Biomedical Research Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moxidectin

Ivermectin

Arm Description

Moxidectin 8mg

Ivermectin 150 mcg/kg

Outcomes

Primary Outcome Measures

skin microfilaria density (mf/mg)

Secondary Outcome Measures

skin microfilaria density (mf/mg)
skin microfilaria density (mf/mg)
skin microfilaria density (mf/mg)
skin microfilaria reduction from baseline
skin microfilaria reduction from baseline
skin microfilaria reduction from baseline
skin microfilaria reduction from baseline
proportion of subjects with undetectable levels of skin microfilaria
proportion of subjects with undetectable levels of skin microfilaria
proportion of subjects with undetectable levels of skin microfilaria
proportion of subjects with undetectable levels of skin microfilaria
percent reduction in microfilaria levels in the anterior chamber of the eye

Full Information

First Posted
November 13, 2008
Last Updated
January 29, 2018
Sponsor
Medicines Development for Global Health
Collaborators
World Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00790998
Brief Title
Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection
Official Title
A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicines Development for Global Health
Collaborators
World Health Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onchocerciasis
Keywords
onchocerciasis, river blindness, onchocerca volvulus, moxidectin, ivermectin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1497 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moxidectin
Arm Type
Experimental
Arm Description
Moxidectin 8mg
Arm Title
Ivermectin
Arm Type
Active Comparator
Arm Description
Ivermectin 150 mcg/kg
Intervention Type
Drug
Intervention Name(s)
Moxidectin
Intervention Description
Single dose of moxidectin 2 mg oral tablet x 4
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
Ivermectin, Mectizan, Stromectol
Intervention Description
Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4
Primary Outcome Measure Information:
Title
skin microfilaria density (mf/mg)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
skin microfilaria density (mf/mg)
Time Frame
1 month
Title
skin microfilaria density (mf/mg)
Time Frame
6 months
Title
skin microfilaria density (mf/mg)
Time Frame
18 months
Title
skin microfilaria reduction from baseline
Time Frame
1 month
Title
skin microfilaria reduction from baseline
Time Frame
6 months
Title
skin microfilaria reduction from baseline
Time Frame
12 months
Title
skin microfilaria reduction from baseline
Time Frame
18 months
Title
proportion of subjects with undetectable levels of skin microfilaria
Time Frame
1 month
Title
proportion of subjects with undetectable levels of skin microfilaria
Time Frame
6 months
Title
proportion of subjects with undetectable levels of skin microfilaria
Time Frame
12 months
Title
proportion of subjects with undetectable levels of skin microfilaria
Time Frame
18 months
Title
percent reduction in microfilaria levels in the anterior chamber of the eye
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects with Onchocerca volvulus infection Exclusion Criteria: Pregnant or breast feeding women; coincidental loiasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Special Programme for Research and Training in Tropical Diseases (TDR)
Organizational Affiliation
World Health Organization
Official's Role
Study Director
Facility Information:
Facility Name
Centre de Recherche Clinique de Butembo - Université Catholique du Graben
City
Butembo
Country
Congo, The Democratic Republic of the
Facility Name
Centre de Recherche en Maladies Tropicales de l'Ituri
City
Rethy
Country
Congo, The Democratic Republic of the
Facility Name
Onchocerciasis Chemotherapy Research Center
City
Hohoe
Country
Ghana
Facility Name
Liberian Institute for Biomedical Research Clinical Research Center
City
Bolahun
State/Province
Lofa County
Country
Liberia

12. IPD Sharing Statement

Citations:
PubMed Identifier
29361335
Citation
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, Asare S, Attah SK, Olipoh G, Vaillant M, Halleux CM, Kuesel AC. Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial. Lancet. 2018 Oct 6;392(10154):1207-1216. doi: 10.1016/S0140-6736(17)32844-1. Epub 2018 Jan 18. Erratum In: Lancet. 2018 Oct 6;392(10154):1196.
Results Reference
result
PubMed Identifier
35476631
Citation
Bakajika D, Kanza EM, Opoku NO, Howard HM, Mambandu GL, Nyathirombo A, Nigo MM, Kennedy KK, Masembe SL, Mumbere M, Kataliko K, Bolay KM, Attah SK, Olipoh G, Asare S, Vaillant M, Halleux CM, Kuesel AC. Effect of a single dose of 8 mg moxidectin or 150 mug/kg ivermectin on O. volvulus skin microfilariae in a randomized trial: Differences between areas in the Democratic Republic of the Congo, Liberia and Ghana and impact of intensity of infection. PLoS Negl Trop Dis. 2022 Apr 27;16(4):e0010079. doi: 10.1371/journal.pntd.0010079. eCollection 2022 Apr.
Results Reference
derived
Links:
URL
http://dx.doi.org/10.1016/S0140-6736(17)32844-1
Description
Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial

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Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

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