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CompletedNCT00790998Updated Jan 31, 2018

Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

A Phase 3 interventional study of Moxidectin and Ivermectin in Onchocerciasis, sponsored by Medicines Development for Global Health. Completed at 4 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-01-31.

Sponsored by Medicines Development for Global Health · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,497
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Onchocerciasis

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Keywords

  • onchocerciasis
  • river blindness
  • onchocerca volvulus
  • moxidectin
  • ivermectin
03

In context

Onchocerciasis

35 studies on the registry are indexed under Onchocerciasis; 7 are open to participants now.

This study's enrollment of 1,497 is above the median of 216 across 26 interventional studies indexed under Onchocerciasis.

Browse Onchocerciasis studies →

Lead sponsor

Medicines Development for Global Health is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female subjects with Onchocerca volvulus infection

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breast feeding women; coincidental loiasis
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,497 participants (actual)

Study arms

  • Experimental
    Moxidectin

    Moxidectin 8mg

    Drug: Moxidectin

  • Active comparator
    Ivermectin

    Ivermectin 150 mcg/kg

    Drug: Ivermectin

Interventions

  • DrugMoxidectin

    Single dose of moxidectin 2 mg oral tablet x 4

  • DrugIvermectin

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

    Also known as: Ivermectin, Mectizan, Stromectol

06

What researchers measure

Primary outcomes

  1. skin microfilaria density (mf/mg)

    Time frame: 12 months

Secondary outcomes

  1. skin microfilaria density (mf/mg)

    Time frame: 1 month

  2. skin microfilaria density (mf/mg)

    Time frame: 6 months

  3. skin microfilaria density (mf/mg)

    Time frame: 18 months

  4. skin microfilaria reduction from baseline

    Time frame: 1 month

  5. skin microfilaria reduction from baseline

    Time frame: 6 months

  6. skin microfilaria reduction from baseline

    Time frame: 12 months

  7. skin microfilaria reduction from baseline

    Time frame: 18 months

  8. proportion of subjects with undetectable levels of skin microfilaria

    Time frame: 1 month

  9. proportion of subjects with undetectable levels of skin microfilaria

    Time frame: 6 months

  10. proportion of subjects with undetectable levels of skin microfilaria

    Time frame: 12 months

  11. proportion of subjects with undetectable levels of skin microfilaria

    Time frame: 18 months

  12. percent reduction in microfilaria levels in the anterior chamber of the eye

    Time frame: 12 months

07

Study locations

4 sites
  • 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, Congo, The Democratic Republic of the
  • Onchocerciasis Chemotherapy Research Center
    Hohoe, Ghana
  • Liberian Institute for Biomedical Research Clinical Research Center
    Bolahun, Lofa County, Liberia
08

References and documents

Publications

  • 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. doi: 10.1016/S0140-6736(18)32403-6. PubMed 29361335 ↗
  • 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. PubMed 35476631 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of Feb 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2008
First posted
Nov 14, 2008
Start
Apr 2009
Primary completionActual
Feb 2012
CompletionActual
May 2012
Last update
Jan 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00790998
Lead sponsor
Medicines Development for Global Health
Collaborators
World Health Organization
Responsible party
Sponsor
First posted
Nov 14, 2008
Start date
Apr 2009
Primary completion
Feb 2012
Completion
May 2012
Last update
Jan 31, 2018

Study contacts

Special Programme for Research and Training in Tropical Diseases (TDR)
study director · World Health Organization

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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