A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Loiasis

In brief

The aim of the study is to evaluate the safety and efficacy of a 3- and 5-day course of levamisole (2.5 mg/kg) in management of loiasis microfilaremia.

Key facts

Study ID

NCT06252961

Run by

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

People needed

99

Starts

2024-06-21

Expected to finish

2026-02-01

Last updated by the study team

2024-09-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Consent informed, written, signed and dated
• Women or men aged 18 to 65 years inclusive
• Carrier of L. loa microfilaremia
• Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 90 kg
• In good health, as determined by medical questionnaire and general clinical examination
• Absence of acute or chronic infection :

You may not qualify if…

• Participation in any study other than a purely observational study, within the 4 weeks preceding this study (determined by the theoretical date of the first administration of levamisole or placebo)
• Any vaccination within 4 weeks previous to this study
• Infection requiring treatment in the 10 days previous to this study, as determined by the anamnesis during the medical interview (e.g. pulmonary infection , digestive or skin infection; with or without antibiotic treatment)
• Treatment with clozapine, phenothiazines, sulfasalazine, carbamazepine, synthetic antithyroid drugs, ticlopidine, cimetidine, and gold salts: whether it was long-term treatment, or treatment given as a single dose 10 days before the start of treatment for the clinical trial (precaution with regard to the risk of agranulocytosis of immuno-allergic or toxic origin)
• Known immunosuppressive pathology (by self-report)
• Past or present history of neurological (including epilepsy) or neuropsychiatric disease
• History of agranulocytosis
• Use of cocaine or other drugs of abuse in the 72 hours preceding administration of the trial treatment, as determined by history during the medical interview
• Any condition, in the opinion of the investigator, that exposes the subject to undue risk
• Known intolerance to levamisole
• Subjects who donated blood in the previous 8 weeks to study entry, with a standard volume (> 500 mL)
• On clinical examination: symptoms, physical signs or laboratory findings suggestive of systemic disorders, including disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other abnormalities that could interfere with the interpretation of trial results. The physician may then give a favorable or unfavorable opinion on the participant's inclusion.
• Ivermectin and/or levamisole taken in the last six months; and/or mebendazole or albendazole taken in the last month
• Pregnant and/or breast-feeding women

Where it is running

• Supervisor — Sibiti, Komono, Republic of the Congo (enrolling)
• General Supervisor — Sibiti, Mokassi, Republic of the Congo (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.