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

NCT04049851 | Completed Phase 2 DMC

• 1 other identifier: C18-57
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Onchocerciasis, Ocular; Loiasis

Outcome Measures

Primary Outcomes (2)

• Incidence of severe adverse events post Moxidectin 2 mg

  Absence of severe adverse events

  1 week

• Incidence of adverse events with Moxidectin 2 mg

  Proportion of adverse events during the first week

  1 week

Secondary Outcomes (3)

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

  Day 7 and Day 15

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

  Day 80, Day 180, and Year 1

• Percentage of individuals without microfilaria post Moxidectin 2 mg

  Day 7, Day 90, Day 180, and Year 1

Study Arms (2)

Moxidectin

EXPERIMENTAL

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

Ivermectin

ACTIVE COMPARATOR

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

Interventions

Moxidectin 2 MG Oral Tablet DRUG

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

Moxidectin

Ivermectin 3Mg Tab 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.

Ivermectin

Placebo oral tablet DRUG

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

Ivermectin; Moxidectin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Center for Research on Filariasis and Other Tropical Diseases, Cameroon: lead

Study Sites (1)

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

Yaoundé, Cameroon

Location

Related Publications (1)

• 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.

  PMID: 38966851 DERIVED

MeSH Terms

Conditions

Onchocerciasis, Ocular; Loiasis

Interventions

moxidectin; Tablets; Ivermectin

Condition Hierarchy (Ancestors)

Eye Infections, Parasitic; Parasitic Diseases; Infections; Onchocerciasis; Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Vector Borne Diseases; Eye Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 8, 2019
• Study Start: April 7, 2022
• Primary Completion: July 22, 2023
• Study Completion: July 22, 2023
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)