NCT00790998

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,497

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2009

Typical duration for phase_3

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 31, 2018

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

November 13, 2008

Last Update Submit

January 29, 2018

Conditions

Onchocerciasis

Keywords

onchocerciasisriver blindnessonchocerca volvulusmoxidectinivermectin

Outcome Measures

Primary Outcomes (1)

  • skin microfilaria density (mf/mg)

    12 months

Secondary Outcomes (12)

  • skin microfilaria density (mf/mg)

    1 month

  • skin microfilaria density (mf/mg)

    6 months

  • skin microfilaria density (mf/mg)

    18 months

  • skin microfilaria reduction from baseline

    1 month

  • skin microfilaria reduction from baseline

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Moxidectin

EXPERIMENTAL

Moxidectin 8mg

Drug: Moxidectin

Ivermectin

ACTIVE COMPARATOR

Ivermectin 150 mcg/kg

Drug: Ivermectin

Interventions

MoxidectinDRUG

Single dose of moxidectin 2 mg oral tablet x 4

Moxidectin
IvermectinDRUG

Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4

Also known as: Ivermectin, Mectizan, Stromectol
Ivermectin

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects with Onchocerca volvulus infection

You may not qualify if:

  • Pregnant or breast feeding women; coincidental loiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre de Recherche Clinique de Butembo - Université Catholique du Graben

Butembo, Democratic Republic of the Congo

Location

Centre de Recherche en Maladies Tropicales de l'Ituri

Rethy, Democratic Republic of the Congo

Location

Onchocerciasis Chemotherapy Research Center

Hohoe, Ghana

Location

Liberian Institute for Biomedical Research Clinical Research Center

Bolahun, Lofa County, Liberia

Location

Related Publications (2)

  • 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.

    PMID: 29361335RESULT

  • 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.

    PMID: 35476631DERIVED

Related Links

MeSH Terms

Conditions

OnchocerciasisOnchocerciasis, Ocular

Interventions

moxidectinIvermectin

Condition Hierarchy (Ancestors)

FilariasisSpirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsSkin Diseases, ParasiticSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesEye Infections, ParasiticVector Borne DiseasesEye InfectionsEye Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Special Programme for Research and Training in Tropical Diseases (TDR)

    World Health Organization

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

April 1, 2009

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

January 31, 2018

Record last verified: 2013-11

Locations

LI(1)DE(2)GH(1)