NCT04049630

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

Randomized Clinical Trial, Double-blind, Dose-escalating of Drug Intensities, Evaluating the Safety and Efficacy of Levamisole in Loa Loa Microfilaremic Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Programme National de Lutte contre l'Onchocercose, Republic of the Congo · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Onchocerciasis, Ocular
• Loiasis

Interventions

Type	Name	Description
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	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	LEV 2,5 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.

Timeline

• Start date: 2021-01-16
• Primary completion: 2021-04-24
• Completion: 2021-07-15
• First posted: 2019-08-08
• Last updated: 2021-09-20

Locations

1 site across 1 country: Republic of the Congo