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New treatment option for Loiasis
Official title A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects
ClinicalTrials.gov ID: NCT06252961
What this study is testing
What is Levamisole 3 days?
Levamisole 3 days is an investigational medicine, being studied as a potential treatment for loiasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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
You likely can't join if
- Participation in any study other than a purely observational study, within the 4 weeks preceding this study (determined by the theoretical date of...
- 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...
- Treatment with clozapine, phenothiazines, sulfasalazine, carbamazepine, synthetic antithyroid drugs, ticlopidine, cimetidine, and gold salts: whether...
- Known immunosuppressive pathology (by self-report)
- Past or present history of neurological (including epilepsy) or neuropsychiatric disease
See the full eligibility criteria
- 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 :
- 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 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...
- 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
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sibiti, Komono, Republic of the Congo
- Sibiti, Mokassi, Republic of the Congo
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sibiti, Komono, Republic of the Congo; Sibiti, Mokassi, Republic of the Congo. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.