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

NCT04049630 | Completed Phase 2 DMC

• 1 other identifier: EOLoa/LEV
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at evaluating the safety and efficacy of levamisole in patients with loiasis infection.

Conditions

Onchocerciasis, Ocular; Loiasis

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of levamisole

  Absence of severe adverse events during the first week

  1 week

• Incidence of adverse events with levamisole

  Proportion of adverse events during the first week

  1 week

Secondary Outcomes (2)

• Efficacy of levamisole

  Day 2, Day 7, and Month 1

• Proportion of individuals without microfilariae of Loa loa

  Day 7 and 1 Month

Study Arms (4)

LEV 1 mg/kg

EXPERIMENTAL

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; Drug: Placebo

LEV 1,5 mg/kg

EXPERIMENTAL

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; Drug: Placebo

LEV 2,5 mg/kg

EXPERIMENTAL

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.

Drug: LEV 2,5 mg/kg; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Tablets of placebo will be administrated to the participant in single dose only one time.

Drug: Placebo

Interventions

LEV 1 mg/kg DRUG

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.

LEV 1 mg/kg

LEV 1,5 mg/kg DRUG

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.

LEV 1,5 mg/kg

LEV 2,5 mg/kg DRUG

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.

LEV 2,5 mg/kg

Placebo DRUG

5 tablets of placebo will be administrated to the participants.

LEV 1 mg/kg; LEV 1,5 mg/kg; LEV 2,5 mg/kg; Placebo

Eligibility Criteria

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

You may qualify if:

• 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

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 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)
• 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)

Sponsors & Collaborators

• Programme National de Lutte contre l'Onchocercose, Republic of the Congo: lead

Study Sites (1)

Secteur opérationnelle de la Santé, Ministère de la Santé et de la Population

Sibiti, Republic of the Congo

Location

Related Publications (1)

• Campillo JT, Bikita P, Hemilembolo M, Louya F, Missamou F, Pion SDS, Boussinesq M, Chesnais C. Safety and Efficacy of Levamisole in Loiasis: A Randomized, Placebo-controlled, Double-blind Clinical Trial. Clin Infect Dis. 2022 Aug 24;75(1):19-27. doi: 10.1093/cid/ciab906.

  PMID: 34651190 DERIVED

MeSH Terms

Conditions

Onchocerciasis, Ocular; Loiasis

Interventions

Levamisole

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)

Thiazoles; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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 GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 8, 2019
• Study Start: January 16, 2021
• Primary Completion: April 24, 2021
• Study Completion: July 15, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

RE (1)