Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 mg Ivermectin-controlled in Loa Loa Microfilaremic Patients (EOLoa)
Primary Purpose
Onchocerciasis, Ocular, Loiasis
Status
Active
Phase
Phase 2
Locations
Cameroon
Study Type
Interventional
Intervention
Moxidectin 2 MG Oral Tablet
Ivermectin 3Mg Tab
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Onchocerciasis, Ocular
Eligibility Criteria
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
Sites / Locations
- Centre de recherche sur les filarioses et autres maladies tropicales (CRFilMT)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Moxidectin
Ivermectin
Arm Description
Outcomes
Primary Outcome Measures
Incidence of severe adverse events post Moxidectin 2 mg
Absence of severe adverse events
Incidence of adverse events with Moxidectin 2 mg
Proportion of adverse events during the first week
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT04049851
First Posted
July 26, 2019
Last Updated
July 7, 2023
Sponsor
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
1. Study Identification
Unique Protocol Identification Number
NCT04049851
Brief Title
Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 mg Ivermectin-controlled in Loa Loa Microfilaremic Patients
Acronym
EOLoa
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
August 14, 2023 (Anticipated)
Study Completion Date
August 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims at evaluating the safety and efficacy of Moxidectin 2 mg in patients with low intensities of microfilariae of Loa loa.
Detailed Description
This clinical trial will be randomized, double blind, and will compare Moxidectin to ivermectin. This study will be conducted in Cameroon.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onchocerciasis, Ocular, Loiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moxidectin
Arm Type
Experimental
Arm Title
Ivermectin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Moxidectin 2 MG Oral Tablet
Intervention Description
One Moxidectin 2 mg tablet will be blinded and will be administrated with 3 tablets of placebo.
Intervention Type
Drug
Intervention Name(s)
Ivermectin 3Mg Tab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Placebo will be administrated with Moxidectin or ivermectin. Each participant will have 4 tablets in total.
Primary Outcome Measure Information:
Title
Incidence of severe adverse events post Moxidectin 2 mg
Description
Absence of severe adverse events
Time Frame
1 week
Title
Incidence of adverse events with Moxidectin 2 mg
Description
Proportion of adverse events during the first week
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Proportion of reduction of the microfilarial densities of Loa loa : short term efficacy
Description
Proportion of reduction of the microfilarial densities of Loa loa at Day 7 and Day 15
Time Frame
Day 7 and Day 15
Title
Proportion of reduction of the microfilarial densities of Loa loa : long term efficacy
Description
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
Title
Percentage of individuals without microfilaria post Moxidectin 2 mg
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Centre de recherche sur les filarioses et autres maladies tropicales (CRFilMT)
City
Yaoundé
Country
Cameroon
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 mg Ivermectin-controlled in Loa Loa Microfilaremic Patients
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