Onchocerciasis, OcularPhase 2EOLoaNCT04049851
Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 mg Ivermectin-controlled in Loa Loa Microfilaremic Patients
A Phase 2 study testing Moxidectin 2 MG Oral Tablet and Ivermectin 3Mg Tab in people with Onchocerciasis, Ocular and Loiasis, run by Center for Research on Filariasis and Other Tropical Diseases, Cameroon at 1 site in Cameroon.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Onchocerciasis, Ocular, Loiasis
- What is being tested?
- Moxidectin 2 MG Oral Tablet and Ivermectin 3Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCameroon
- Study dates
- 7 Apr 2022to 22 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Centre de recherche sur les filarioses et autres maladies tropicales (CRFilMT)
Yaoundé
About this study
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
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.
- Conditions
- Onchocerciasis, Ocular, Loiasis
- Being tested
- Moxidectin 2 MG Oral Tablet, Ivermectin 3Mg Tab, Placebo oral tablet
- Medical subject headings
- Onchocerciasis, Ocular, Loiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxidectin 2 MG Oral TabletDrug
One Moxidectin 2 mg tablet will be blinded and will be administrated with 3 tablets of placebo.
Ivermectin 3Mg TabDrug
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.
Placebo oral tabletDrug
Placebo will be administrated with Moxidectin or ivermectin. Each participant will have 4 tablets in total.
| Study group | Role | What they receive |
|---|---|---|
| Moxidectin | Experimental | Not described Receives: Drug: Moxidectin 2 MG Oral Tablet; Drug: Placebo oral tablet |
| Ivermectin | Active comparator | Not described Receives: Drug: Ivermectin 3Mg Tab; Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe adverse events post Moxidectin 2 mg
Absence of severe adverse events
Measured: 1 week
Incidence of adverse events with Moxidectin 2 mg
Proportion of adverse events during the first week
Measured: 1 week
Secondary outcomes (3)
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
Measured: 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
Measured: Day 80, Day 180, and Year 1
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
Measured: Day 7, Day 90, Day 180, and Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start7 Apr 2022
- Primary completion22 Jul 2023
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Onchocerciasis, OcularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Research on Filariasis and Other Tropical Diseases, Cameroon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049851
- Sponsor's protocol ID
- C18-57
- Acronym
- EOLoa
- Status last verified
- Feb 2025
- First submitted
- 26 Jul 2019
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wafeu GS, Lepage TM, Campillo JT, Efon-Ekangouo A, Nana-Djeunga HC, Nzune-Toche N, Domche A, Sumo L, Njitchouang GR, Tsasse MAF, Bopda J, Balog YA, Niamsi-Emalio Y, Mbickmen-Tchana S, Talla GK, Kana YSN, Messina FDM, Pion SD, Kuesel AC, Kamgno J, Boussinesq M, Chesnais CB. Safety and Short-term Efficacy of a Single Dose of 2 mg Moxidectin in Loa loa-Infected Individuals: A Double-Blind, Randomized Ivermectin-Controlled Trial With Ascending Microfilarial Densities. Open Forum Infect Dis. 2024 Apr 25;11(7):ofae240. doi: 10.1093/ofid/ofae240. eCollection 2024 Jul.
PubMed 38966851
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04049851
- Acronym / sponsor ID
- EOLoa / C18-57
- Conditions
- Onchocerciasis, Ocular, Loiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Center for Research on Filariasis and Other Tropical Diseases, CameroonUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxidectin | Experimental | Drug: Moxidectin 2 MG Oral Tablet, Drug: Placebo oral tablet |
| Ivermectin | Active comparator | Drug: Ivermectin 3Mg Tab, Drug: Placebo oral tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxidectin 2 MG Oral TabletOne Moxidectin 2 mg tablet will be blinded and will be administrated with 3 tablets of placebo. | Drug | Moxidectin |
| Ivermectin 3Mg Tab3 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. | Drug | Ivermectin |
| Placebo oral tabletPlacebo will be administrated with Moxidectin or ivermectin. Each participant will have 4 tablets in total. | Drug | Ivermectin, Moxidectin |
Primary outcome
Incidence of severe adverse events post Moxidectin 2 mg
Time frame: 1 week
Absence of severe adverse events
Incidence of adverse events with Moxidectin 2 mg
Time frame: 1 week
Proportion of adverse events during the first week
3 secondary outcomes
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 : long term efficacy
Time frame: Day 80, Day 180, and Year 1
Percentage of individuals without microfilaria post Moxidectin 2 mg
Time frame: Day 7, Day 90, Day 180, and Year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Derived from this study: PubMed 38966851Wafeu GS, Lepage TM, Campillo JT, Efon-Ekangouo A, Nana-Djeunga HC, Nzune-Toche N, Domche A, Sumo L, Njitchouang GR, Tsasse MAF, Bopda J, Balog YA, Niamsi-Emalio Y, Mbickmen-Tchana S, Talla GK, Kana YSN, Messina FDM, Pion SD, Kuesel AC, Kamgno J, Boussinesq M, Chesnais CB. Safety and Short-term Efficacy of a Single Dose of 2 mg Moxidectin in Loa loa-Infected Individuals: A Double-Blind, Randomized Ivermectin-Controlled Trial With Ascending Microfilarial Densities. Open Forum Infect Dis. 2024 Apr 25;11(7):ofae240. doi: 10.1093/ofid/ofae240. eCollection 2024 Jul.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moxidectin 2 MG Oral Tablet and Ivermectin 3Mg Tab in people with Onchocerciasis, Ocular and Loiasis, run by Center for Research on Filariasis and Other Tropical Diseases, Cameroon at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe adverse events post Moxidectin 2 mg (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.