Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01635777

Enrollment

Registered

2012-07-10

Start date

2007-07-31

Completion date

2010-12-31

Last updated

2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PKDL

Keywords

PKDL, miltefosine

Brief summary

Miltefosine efficacy will be \>85%

Interventions

DRUGMiltefosine

2.5 mg/kg/day for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 12 years or older * nodules and papules consistent with post kala-azar dermal leishmaniasis * parasitological confirmation of Leishmania infection

Exclusion criteria

* platelet count \<100x 109/l, * leukocyte count \<2.5 x 109/l , * hemoglobin \< 8.0 g/100 ml , * liver function tests \>3 times upper limit of normal range, * bilirubin \>2 times upper limit of normal range, * serum creatinine or blood urea nitrogen \>1.5 times upper limit of normal range); * any non-compensated or uncontrolled condition, * lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter; * treatment with any anti-leishmanial drug within the previous 12 weeks.

Design outcomes

Primary

Measure	Time frame
Cure rate	12 months after end of treatment

Secondary

Measure	Time frame	Description
adverse events	during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group	gastrointestinal events: vomiting and diarrhea

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026