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

NCT ID: NCT04049851

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-07
• Study Completion Date: 2023-07-22

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.

Conditions

Onchocerciasis, Ocular; Loiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Moxidectin

Group Type: EXPERIMENTAL

Moxidectin 2 MG Oral Tablet

Intervention Type: DRUG

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

Placebo oral tablet

Intervention Type: DRUG

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

Ivermectin

Group Type: ACTIVE_COMPARATOR

Ivermectin 3Mg Tab

Intervention Type: DRUG

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 tablet

Intervention Type: DRUG

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

Interventions

Moxidectin 2 MG Oral Tablet

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

Intervention Type: DRUG

Ivermectin 3Mg Tab

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

Placebo oral tablet

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Research on Filariasis and Other Tropical Diseases, Cameroon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de recherche sur les filarioses et autres maladies tropicales (CRFilMT)

Yaoundé, , Cameroon

Countries

Cameroon

References

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.

Reference Type: DERIVED

PMID: 38966851 (View on PubMed)

Other Identifiers

C18-57

Identifier Type: -

Identifier Source: org_study_id