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CompletedNCT04049851EOLoaUpdated Feb 24, 2025

Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 Mg Ivermectin-controlled in Loa Loa Microfilaremic Patients

A Phase 2 interventional study of Moxidectin 2 MG Oral Tablet and Ivermectin 3Mg Tab in Onchocerciasis, Ocular and Loiasis, sponsored by Center for Research on Filariasis and Other Tropical Diseases, Cameroon. Completed at 1 site in Cameroon. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by Center for Research on Filariasis and Other Tropical Diseases, Cameroon · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

This study aims at evaluating the safety and efficacy of Moxidectin 2 mg in patients with low intensities of microfilariae of Loa loa.

Read the detailed description

This clinical trial will be randomized, double blind, and will compare Moxidectin to ivermectin. This study will be conducted in Cameroon.

02

Conditions studied

  • Onchocerciasis, Ocular
  • Loiasis
03

In context

Lead sponsor

Center for Research on Filariasis and Other Tropical Diseases, Cameroon is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

  • written, signed (or with a cross) and dated
  • Men aged 18 to 65 included (women not included in the study)
  • Microfilarial density between 1 and 1,000 mf/mL
  • body weight ≥ 45 kg and less than 85 kg
  • Good general condition, as determined by the medical questionnaire and clinical examination
  • Hematological parameters and adequate renal and hepatic functions, such as:

    • Leukocytes ≥ 2,800 and ≤ 11,300 cells/mL
    • ≥ 10.0 g/dL
    • ≥100,000/mm3
    • Serum creatinine ≤ 2.5 upper limit (UL) of the laboratory
    • Total bilirubinemia ≤ 2.5 x UL
    • ALAT ≤ 2.5 x UL
    • Negative urinary strip: absence of leucocyturia, hematuria, and proteinuria (in case of positivity, a second urinary strip test will be made, for confirmation)

Exclusion criteria

Exclusion Criteria:

  • Participation in any study other than purely observational, in the 4 weeks preceding this study (determined by the theoretical date of administration of MOX-2 mg or IVM).
  • Person who has taken IVM in the last 6 months
  • Any vaccination in the 4 weeks preceding this study
  • Acute infection requiring a treatment in the 10 days preceding this study, determined by the anamnesis during the medical interview (example: pulmonary infection, ENT, digestive, cutaneous, with implementation of an antibiotic treatment or not)
  • Long-term antiretroviral therapy (protease inhibitor, non-nucleoside reverse transcriptase inhibitor), or treatment with ampicillin or chloramphenicol within 10 days prior to administration of the test drug
  • History or presence of neurological (including epilepsy) or neuropsychiatric disease
  • Excessive consumption of alcohol or other drug abuse within 72 hours prior to the administration of the test treatment determined by the medical history during the medical interview.
  • Any condition, in the opinion of the investigator, which exposes the subject to an undue risk
  • Subjects who donated blood in the 8 weeks prior to study entry, with a standard volume (> 500 mL)
  • Known intolerance to IVM, MOX or any of the (including placebo)
  • During the clinical examination: symptoms, physical signs or biological constants suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric disorders and other abnormalities likely to interfere with the interpretation results of the test. The doctor may then give a favorable or unfavorable opinion for the inclusion of the participant
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Moxidectin

    Drug: Moxidectin 2 MG Oral Tablet · Drug: Placebo oral tablet

  • Active comparator
    Ivermectin

    Drug: Ivermectin 3Mg Tab · Drug: Placebo oral tablet

Interventions

  • One Moxidectin 2 mg tablet will be blinded and will be administrated with 3 tablets of placebo.

  • 3 ivermectin tablets (or 4 according to the weight) will be blinded and will be administrated with 1 (or 0 according to the weight) tablet of placebo.

  • DrugPlacebo oral tablet

    Placebo will be administrated with Moxidectin or ivermectin. Each participant will have 4 tablets in total.

06

What researchers measure

Primary outcomes

  1. Incidence of severe adverse events post Moxidectin 2 mg

    Absence of severe adverse events

    Time frame: 1 week

  2. Incidence of adverse events with Moxidectin 2 mg

    Proportion of adverse events during the first week

    Time frame: 1 week

Secondary outcomes

  1. Proportion of reduction of the microfilarial densities of Loa loa : short term efficacy

    Proportion of reduction of the microfilarial densities of Loa loa at Day 7 and Day 15

    Time frame: Day 7 and Day 15

  2. Proportion of reduction of the microfilarial densities of Loa loa : long term efficacy

    Proportion of reduction of the microfilarial densities of Loa loa at Day 80, Day 180, and Day 365

    Time frame: Day 80, Day 180, and Year 1

  3. Percentage of individuals without microfilaria post Moxidectin 2 mg

    Percentage of individuals without microfilariae of Loa loa at Day 7, Day 90, Day 180, and Day 365

    Time frame: Day 7, Day 90, Day 180, and Year 1

07

Study locations

1 site
  • Centre de recherche sur les filarioses et autres maladies tropicales (CRFilMT)
    Yaoundé, Cameroon
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04049851
Lead sponsor
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
Responsible party
Sponsor
First posted
Aug 8, 2019
Start date
Apr 7, 2022
Primary completion
Jul 22, 2023
Completion
Jul 22, 2023
Last update
Feb 24, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Moxidectin

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