A Phase 2 interventional study of LEV 1 mg/kg and LEV 1,5 mg/kg in Onchocerciasis, Ocular and Loiasis, sponsored by Programme National de Lutte contre l'Onchocercose, Republic of the Congo. Completed at 1 site in Congo. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-20.
Sponsored by Programme National de Lutte contre l'Onchocercose, Republic of the Congo · Phase 2, Interventional, and Treatment
This study aims at evaluating the safety and efficacy of levamisole in patients with loiasis infection.
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.
Programme National de Lutte contre l'Onchocercose, Republic of the Congo is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Tablets of placebo will be administrated to the participant in single dose only one time.
Drug: Placebo
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.
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.
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.
5 tablets of placebo will be administrated to the participants.
Safety and tolerability of levamisole
Absence of severe adverse events during the first week
Time frame: 1 week
Incidence of adverse events with levamisole
Proportion of adverse events during the first week
Time frame: 1 week
Efficacy of levamisole
Proportion of reduction of the microfilarial density of Loa loa at Day 2, Day 7, and Month 1
Time frame: Day 2, Day 7, and Month 1
Proportion of individuals without microfilariae of Loa loa
Proportion of individuals with a diminution of 40% and 80% and more of the microfilarial density at Day 7 and Month 1
Time frame: Day 7 and 1 Month
Ran from Jan 2021 to primary completion in Apr 2021, 3 months.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Onchocerciasis, Ocular
Programme National de Lutte contre l'Onchocercose, Republic of the Congo