- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04049851
Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 mg Ivermectin-controlled in Loa Loa Microfilaremic Patients (EOLoa)
July 7, 2023 updated by: Center for Research on Filariasis and Other Tropical Diseases, Cameroon
Randomized Clinical Trial, Double-blind, Single-dose Drug and Escalating Infection Intensities, Evaluating the Safety and Efficacy of Moxidectin 2 mg, Ivermectin-controlled, in Loa Loa Microfilaremic Patients
This study aims at evaluating the safety and efficacy of Moxidectin 2 mg in patients with low intensities of microfilariae of Loa loa.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This clinical trial will be randomized, double blind, and will compare Moxidectin to ivermectin.
This study will be conducted in Cameroon.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Yaoundé, Cameroon
- Centre de recherche sur les filarioses et autres maladies tropicales (CRFilMT)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Informed consent 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
- Hemoglobin ≥ 10.0 g/dL
- Platelets ≥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:
- 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 excipients (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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Moxidectin
|
One Moxidectin 2 mg tablet will be blinded and will be administrated with 3 tablets of placebo.
Placebo will be administrated with Moxidectin or ivermectin.
Each participant will have 4 tablets in total.
|
Active Comparator: Ivermectin
|
Placebo will be administrated with Moxidectin or ivermectin.
Each participant will have 4 tablets in total.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of severe adverse events post Moxidectin 2 mg
Time Frame: 1 week
|
Absence of severe adverse events
|
1 week
|
Incidence of adverse events with Moxidectin 2 mg
Time Frame: 1 week
|
Proportion of adverse events during the first week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of reduction of the microfilarial densities of Loa loa : short term efficacy
Time Frame: Day 7 and Day 15
|
Proportion of reduction of the microfilarial densities of Loa loa at Day 7 and Day 15
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Day 7 and Day 15
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Proportion of reduction of the microfilarial densities of Loa loa : long term efficacy
Time Frame: Day 80, Day 180, and Year 1
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Proportion of reduction of the microfilarial densities of Loa loa at Day 80, Day 180, and Day 365
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Day 80, Day 180, and Year 1
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Percentage of individuals without microfilaria post Moxidectin 2 mg
Time Frame: Day 7, Day 90, Day 180, and Year 1
|
Percentage of individuals without microfilariae of Loa loa at Day 7, Day 90, Day 180, and Day 365
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Day 7, Day 90, Day 180, and Year 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2022
Primary Completion (Estimated)
August 14, 2023
Study Completion (Estimated)
August 14, 2023
Study Registration Dates
First Submitted
July 26, 2019
First Submitted That Met QC Criteria
August 6, 2019
First Posted (Actual)
August 8, 2019
Study Record Updates
Last Update Posted (Actual)
July 11, 2023
Last Update Submitted That Met QC Criteria
July 7, 2023
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Eye Diseases
- Vector Borne Diseases
- Parasitic Diseases
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Spirurida Infections
- Secernentea Infections
- Nematode Infections
- Helminthiasis
- Filariasis
- Eye Infections
- Eye Infections, Parasitic
- Onchocerciasis
- Onchocerciasis, Ocular
- Anti-Infective Agents
- Antiparasitic Agents
- Antinematodal Agents
- Anthelmintics
- Ivermectin
- Moxidectin
Other Study ID Numbers
- C18-57
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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