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Miltefosine · 1 trial · 1 indication
Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.
| Arm | Type | Description |
|---|---|---|
| 1.1 | EXPERIMENTAL | Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine. |
| 1.2 | ACTIVE_COMPARATOR | Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment). |
| 2.1 | EXPERIMENTAL | Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine. |
| 2.2 | ACTIVE_COMPARATOR | Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment). |
| Name | Type | Description |
|---|---|---|
| Miltefosine. | DRUG | Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day. |
| Meglumine antimoniate. | DRUG | Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day. |
Inclusion Criteria: * Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test). * Number of lesions: 1 ...
Miltefosine is used for the treatment of Cutaneous Leishmaniasis in Brazil. It is a small molecule being developed as a therapeutic option for this condition. The drug has been studied in a clinical trial setting in Brazil, with the aim of addressing this infectious disease.
Miltefosine is being developed by COSCIENS Biopharma Inc., a company listed on the stock exchange under the ticker CSCI. The company is advancing this small molecule through clinical development for the treatment of Cutaneous Leishmaniasis in Brazil.
Miltefosine is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 2 trial for Miltefosine has been completed, and the drug remains under investigation for its intended use.
Miltefosine has been studied in a clinical trial with the identifier NCT00600548, titled "Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)". This Phase 2 trial was completed and enrolled 180 participants. The trial was conducted in Brazil and included patients aged 2 years and older.
Miltefosine is the drug name used in clinical development. No alternative names have been established for this drug in the available information. It is identified solely as Miltefosine in the context of its development for Cutaneous Leishmaniasis.