Miltefosine to Treat Mucocutaneous Leishmaniasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2011 by Paladin Labs (USA) Inc.
Sponsor:
Information provided by:
Paladin Labs (USA) Inc.
ClinicalTrials.gov Identifier:
NCT01050907
First received: January 12, 2010
Last updated: January 18, 2011
Last verified: January 2011
  Purpose

The purpose of this Treatment IND is to make miltefosine available for mucocutaneous leishmaniasis patients presenting in the United States.

If entrance criteria are met, subjects with mucosal or cutaneous leishmaniasis will receive miltefosine at a targeted dose of 2.5 mg/kg/day for 28 days. During treatment at weeks 1, 2, and 4, the patient will return to the treatment facility to be assessed for adverse events. Blood for transaminase and creatinine values will be drawn at the midpoint and at the end of therapy.

Patients will return to the treatment facility to be examined clinically at 6 wks (ie, 2 wks after the end of therapy), 3 months (2 months after therapy), and 7 months (6 months after treatment) for ML and CL patients, and also at 13 months (12 months after treatment) for ML patients.


Condition Intervention Phase
Leishmaniasis, Mucocutaneous
Cutaneous Leishmaniasis
Drug: miltefosine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Mucocutaneous Leishmaniasis With Miltefosine

Resource links provided by NLM:


Further study details as provided by Paladin Labs (USA) Inc.:

Primary Outcome Measures:
  • cure rate at the end of follow up [ Time Frame: 6 months (CL) and 12 months (ML) post therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • symptomatic adverse effects: gastrointestinal [ Time Frame: days 1-28 of therapy ] [ Designated as safety issue: Yes ]
  • laboratory adverse effects: creatinine or LFT elevation [ Time Frame: days 1-28 of therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: miltefosine Drug: miltefosine
2.5 mg/kg/day for 28 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is the subject a male or female at least 18 years of age?
  2. Does the subject weigh at least 30 kg?
  3. Does the subject have a diagnosis of ML or CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes of lesion material, 2) microscopic identification of amastigotes in stained lesion tissue, 3) PCR of lesion material?
  4. In the opinion of the investigator, is the subject capable of understanding and complying with the protocol?
  5. If female and of child-bearing potential, did the subject have a negative pregnancy test during screening and agree to use an acceptable method of birth control during the treatment phase and for 6 months after treatment is completed?
  6. Has the patient signed informed consent?

Exclusion Criteria:

  1. Is the subject a female who is breast-feeding?
  2. Does the subject have a clinically significant medical disorder?

    • Thrombocyte count <100 x 109/l
    • Leukocyte count <3 x 109/l
    • Haemoglobin <10 g/100 ml
    • ASAT, ALAT >2 times upper limit of normal range
    • Bilirubin >1.5 times upper limit of normal range
    • Serum creatinine >1.5 times upper limit of normal range
    • Major surgery within last 2 weeks
    • Any non-compensated or uncontrolled condition
  3. In the last 4 weeks up to the present, has the subject received other treatment for leishmaniasis, including any medication with pentavalent antimony; amphotericin B, paromomycin, or imidazoles?
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050907

Contacts
Contact: Jonathan Berman, MD 301-922-2097 jberman@fasttrackresearch.com
Contact: Janet Ransom, PhD 301-762-5707 jransom@fasttrackresearch.com

Locations
United States, Maryland
for this treatment IND, each Physician will enter patients at his/her own facility. Below data is for Protocol central contact Recruiting
Bethesda, Maryland, United States, 20852
Contact: Jonathan Berman, MD    391-922-2097    jberman@fasttrackresearch.com   
NIH Recruiting
Bethesda, Maryland, United States, 20892
Contact: Ted Nash, MD    301-496-6920    tnash@niaid.nih.gov   
Principal Investigator: Ted Nash, MD         
Sponsors and Collaborators
Paladin Labs (USA) Inc.
Investigators
Principal Investigator: Jonathan Berman, MD Fast Track Drugs and Biologics LLC
  More Information

No publications provided

Responsible Party: pending, Paladin labs (USA) c/o Paladin Labs Inc 100 Blvd. Alexis Nihon, Suite 600 St-Laurent, Québec H4M 2P2
ClinicalTrials.gov Identifier: NCT01050907     History of Changes
Other Study ID Numbers: PAL-MILT-201
Study First Received: January 12, 2010
Last Updated: January 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Paladin Labs (USA) Inc.:
leishmaniasis
cutaneous disease
mucosal disease
miltefosine

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Leishmaniasis, Mucocutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Miltefosine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on September 16, 2014