A clinical phase IIa randomized, ascending dose, placebo-controlled, assessor-blind, safety, tolerability and efficacy study of orally administered Moxidectin in subjects with microfilaraemic Loa loa infectio
- Conditions
- Loiasis
- Registration Number
- PACTR202303704849277
- Lead Sponsor
- Bernhard Nocht Institut for Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 165
•Both sexes, Aged 18 to 65 years, inclusive
•Body weight = 40 kg
•Good general condition, as determined by the medical questionnaire and clinical examination
•Hematological parameters and adequate renal and hepatic functions, such as:
oLeukocytes = 3,000 and = 11,300 cells/ml
oHemoglobin = 8.0 g/dl
oPlatelets =75,000/mm3
oSerum creatinine = 2.5 x ULN
oTotal bilirubinemia = 1.5 x ULN
oALT = 3.0 x ULN
oAST = 3.0 x ULN
oNegative urinary strip: absence of leukocyturia, hematuria, and proteinuria (in case of positivity, a second urinary strip test will be made for con-firmation)
•Blood microfilarial density 1-1,000/ml or 1,000-2,000/ ml according to the recruit-ment cohort, respectively
•Written, signed and dated informed con-sent of participant or impartial witness
•Ability to take oral treatment and willing-ness to comply with the study procedures (covered by the informed consent)
•Ongoing participation in any interventional trial.
•Any vaccination within 2 weeks before study drug administration
•Acute infection requiring antibiotic therapy within the last 10 days before study drug administration
•Concomitant administration of drugs of the benzodiazepine class (s. Annex)
•Known past or current history of neurolog-ical or neuropsychiatric disease or epilepsy (incl. previous meningitis, encephalitis)
•History of drug or alcohol abuse
•Any condition, in the investigator's opinion, that places the subject at undue risk
•Subjects who have donated blood within 8 weeks before study entry
•Antifilarial therapy within the previous year (DEC, IVM, albendazole for more than 7 days)
•History of severe drug-induced hypersensi-tivity reaction during previous medical treatment or mild to moderate hypersensi-tivity reaction to macrolytic lactones
•Known intolerance to IVM, MOX or any of the excipients (including placebo)
•Pregnant and breastfeeding women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •The primary purpose of this study is to determine the safety and tolerability of single dose 8 mg moxidectin (MOX) in subjects infected with L. loa compared to ivermectin (IVM).
- Secondary Outcome Measures
Name Time Method To compare the reduction of L. loa microfilarial density (MFD) after single dose MOX therapy to the reduction of MFD after single dose IVM or placebo<br>•To compare the long-term duration of MFD reduction after single dose MOX to the any MFD reduction after single dose IVM or placebo by measuring monthly L.loa MFD over 18 months<br>•To compare the reduction of patient-centred outcomes (clinical manifestations and eosinophil levels) over 18 months post MOX-treatment compared to IVM and placebo<br>