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Trial record 36 of 38 for:    "Elephantiasis" | "Anthelmintics"

Clinical Trial Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients (EOLoa)

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ClinicalTrials.gov Identifier: NCT04049630
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 levamisole in patients with loiasis infection.

Condition or disease Intervention/treatment Phase
Onchocerciasis, Ocular Loiasis Drug: LEV 1 mg/kg Drug: LEV 1,5 mg/kg Drug: Placebo Phase 2

Detailed Description:
This clinical trial will be conducted in Republic of Congo. This is a randomized, double-blind clinical trial. Levamisole will be tested at 1 and 1,5 mg/kg, and compared to placebo (50:50:50). We will perform three cohorts of patients according to the microfilarial density : 500-1,999 mf/ml, 2,000-7,999 mf/ml, and 8,000-20,000 mf/ml.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 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, Dose-escalating of Drug Intensities, Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 15, 2021


Arm Intervention/treatment
Experimental: LEV 1 mg/kg
Tablets of LEV at 1 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.
Drug: LEV 1 mg/kg
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.

Drug: Placebo
5 tablets of placebo will be administrated to the participants.

Experimental: LEV 1,5 mg/kg
Tablet of LEV at 1,5 mg/kg will be administrated to the participant ; in single dose only one time. The number of tablets of LEV of 50 mg or 10 mg will be adapted according to the weight of the participant.
Drug: LEV 1,5 mg/kg
A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.

Drug: Placebo
5 tablets of placebo will be administrated to the participants.

Placebo Comparator: Placebo
Tablets of placebo will be administrated to the participant in single dose only one time.
Drug: Placebo
5 tablets of placebo will be administrated to the participants.




Primary Outcome Measures :
  1. Safety and tolerability of levamisole [ Time Frame: 1 week ]
    Absence of severe adverse events during the first week

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


Secondary Outcome Measures :
  1. Efficacy of levamisole [ Time Frame: Day 2, Day 7, and Month 1 ]
    Proportion of reduction of the microfilarial density of Loa loa at Day 2, Day 7, and Month 1

  2. Proportion of individuals without microfilariae of Loa loa [ Time Frame: Day 7 and 1 Month ]
    Proportion of individuals with a diminution of 80% and more of the microfilarial density at Day 7 and Month 1



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written consent written, signed (or with thumbprint) and dated
  • Aged 18 to 65 inclusive
  • Individual microfilarial density ≥ 500 mf/mL
  • Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 85 kg
  • In good health condition, as determined by the medical questionnaire and the general clinical examination: absence of acute or chronic infection

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 LEV or placebo).
  • 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)
  • Warfarin treatment
  • Treatment with clozapine, phenythiazines, sulfasalazine, carbamazepine, synthetic antithyroid, ticlopidine, cimetidine, and gold salts: whether it is a long-term treatment, or a treatment given in a single dose 10 days before the start of treatment for the clinical trial (precaution of use compared to the risk of agranulocytosis of immuno-allergic or toxic origin)
  • Known immunosuppressive pathology
  • Past or current history of neurological (including epilepsy) or neuropsychiatric disease
  • History of agranulocytosis
  • Consumption of alcohol, taking cocaine or other drugs of abuse in the 72 hours preceding the administration of the treatment of the test determined by the anamnesis during the medical interview
  • Any condition, in the opinion of the investigator, which exposes the subject to an undue risk
  • Known intolerance to levamisole
  • Subjects who gave blood in the 8 weeks before entry into the study, with a standard volume (> 500 mL)
  • 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
  • Taking IVM and / or LEV during the last six months; and / or mebendazole or albendazole in the last month
  • Pregnant and lactating women (based on self-declaration)

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): NCT04049630


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

Locations
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Congo
Secteur opérationnelle de la Santé, Ministère de la Santé et de la Population Not yet recruiting
Sibiti, Congo
Contact: François Missamou, MD       francmissamou2009@gmail.com   
Contact: Charlotte Bizet, PharmD       charlotte.bizet@ird.fr   
Principal Investigator: Francois Missamou, 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: NCT04049630     History of Changes
Other Study ID Numbers: C18-58
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
Levamisole
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antinematodal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents