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Trial record 26 of 38 for:    "Elephantiasis" | "Anthelmintics"

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

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ClinicalTrials.gov Identifier: NCT04049851
Recruitment Status : Not yet recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Onchocerciasis, Ocular Loiasis Drug: Moxidectin 2 MG Oral Tablet Drug: Ivermectin 3Mg Tab Drug: Placebo oral tablet Phase 2

Detailed Description:
This clinical trial will be randomized, double blind, and will compare Moxidectin to ivermectin. This study will be conducted in Cameroon.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Experimental: Moxidectin Drug: Moxidectin 2 MG Oral Tablet
One Moxidectin 2 mg tablet will be blinded and will be administrated with 3 tablets of placebo.

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

Active Comparator: Ivermectin 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.

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




Primary Outcome Measures :
  1. Incidence of severe adverse events post Moxidectin 2 mg [ Time Frame: 1 week ]
    Absence of severe adverse events

  2. Incidence of adverse events with Moxidectin 2 mg [ Time Frame: 1 week ]
    Proportion of adverse events during the first week


Secondary Outcome Measures :
  1. 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

  2. Proportion of reduction of the microfilarial densities of Loa loa : long term efficacy [ Time Frame: Day 80, Day 180, and Year 1 ]
    Proportion of reduction of the microfilarial densities of Loa loa at Day 80, Day 180, and Day 365

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 ≥ 2800 and ≤ 11300 cells / mL
    • Hemoglobin ≥ 11.0 g / dL
    • Platelets ≥ 130.000 / mm3
    • Creatine serum ≤ 1.25 upper limit of the laboratory
    • Total bilirubinemia ≤ 1.25 upper limit of the laboratory
    • ALAT ≤ 1.25 upper limit of the laboratory
    • Negative urinary strip: absence of leukocyturia, hematuria, and proteinuria (urine strip made a second time in case of positivity, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049851


Contacts
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Contact: Cédric Chesnais, MD +33467416162 cedric.chesnais@ird.fr

Locations
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Cameroon
Centre de recherche sur les filarioses et autres maladies tropicales (CRFilMT) Not yet recruiting
Yaoundé, Cameroon
Contact: Joseph Kamgno, MD    237222202442    kamgno@crfilmt.org   
Contact: Charlotte Bizet, PharmD       charlotte.bizet@ird.fr   
Principal Investigator: Joseph Kamgno, MD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04049851     History of Changes
Other Study ID Numbers: C18-57
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Filariasis
Anthelmintics
Onchocerciasis
Onchocerciasis, Ocular
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Eye Infections, Parasitic
Eye Infections
Eye Diseases
Ivermectin
Milbemycin
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents