- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04049630
Clinical Trial Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients (EOLoa)
Randomized Clinical Trial, Double-blind, Dose-escalating of Drug Intensities, Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This clinical trial will be conducted in Republic of Congo. This is a pragmatic and adaptative randomized, double-blind clinical trial. Levamisole will be tested at 1 and 1,5 mg/kg, and compared to placebo (36:36:36); or 2,5 mg/kg compared to placebo (36:36) in case of adaptation of the dose for cohorts II and III.
We will perform three cohorts of patients according to the microfilarial density : 1-1,999 mf/ml, 1-14,999 mf/ml, and all microfilaremic individuals; in order to respect the safety potentially related to loiasis.
The first cohort was to evaluate the most appropriate dose of levamisole, with a possibility to increase (to 2.5 mg/kg) the dose of levamisole for the cohorts II and III in case of lack of efficacy and in case of good safety profil.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Sibiti, Congo
- Secteur opérationnelle de la Santé, Ministère de la Santé et de la Population
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written consent written, signed (or with thumbprint) and dated
- Aged 18 to 65 inclusive
- Individual microfilarial density ≥ 1mf/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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
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.
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.
|
5 tablets of placebo will be administrated to the participants.
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.
|
Experimental: LEV 2,5 mg/kg
Tablet of LEV at 2,5 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.
|
5 tablets of placebo will be administrated to the participants.
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.
|
Placebo Comparator: Placebo
Tablets of placebo will be administrated to the participant in single dose only one time.
|
5 tablets of placebo will be administrated to the participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of levamisole
Time Frame: 1 week
|
Absence of severe adverse events during the first week
|
1 week
|
Incidence of adverse events with levamisole
Time Frame: 1 week
|
Proportion of adverse events during the first week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 2, Day 7, and Month 1
|
Proportion of individuals without microfilariae of Loa loa
Time Frame: Day 7 and 1 Month
|
Proportion of individuals with a diminution of 40% and 80% and more of the microfilarial density at Day 7 and Month 1
|
Day 7 and 1 Month
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EOLoa/LEV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Onchocerciasis, Ocular
-
Center for Research on Filariasis and Other Tropical...Active, not recruitingOnchocerciasis, Ocular | LoiasisCameroon
-
Washington University School of MedicineNational Public Health Institute of LiberiaNot yet recruitingOnchocerciasis | Onchocerciasis, Ocular | Tropical Disease | Onchocercal Subcutaneous Nodule | Onchocerca InfectionLiberia
-
Laboratorios Sophia S.A de C.V.CompletedTolerability | Safety | Ocular Surface | Ocular ComfortMexico
-
Shiraz University of Medical SciencesCompletedIncreased Intra Ocular Pressure (IOP)Iran, Islamic Republic of
-
National Taiwan University HospitalUnknownGlaucoma; Ocular Disorders (I.E. Caused by Ocular Disorders)Taiwan
-
University Hospitals Cleveland Medical CenterWashington University School of MedicineCompleted
-
CHA UniversityHanlim Pharm. Co., Ltd.UnknownGlaucoma | Ocular HypertensiveKorea, Republic of
-
Western Galilee Hospital-NahariyaUnknown
-
Johnson & Johnson Vision Care, Inc.Recruiting
-
Johnson & Johnson Vision Care, Inc.CompletedOcular PhysiologyUnited States
Clinical Trials on LEV 1 mg/kg
-
MedImmune LLCCompletedHealthy SubjectsUnited States
-
Bio Sidus SACompleted
-
Healthgen Biotechnology Corp.RecruitingEmphysema Secondary to Congenital AATDUnited States
-
MedImmune LLCCompleted
-
MedImmune LLCCompleted
-
Ludwig Institute for Cancer ResearchDaiichi Sankyo Co., Ltd.; Austin HealthCompletedMalignant Solid Tumor | Metastatic EphA2 Positive CancerAustralia
-
MedImmune LLCCompleted
-
PfizerCompletedAlzheimer's DiseaseUnited States
-
PfizerCompletedAlzheimer's DiseaseKorea, Republic of, Canada, United States, Australia, United Kingdom, Belgium
-
AM-PharmaCompleted