Miltefosine to Treat Mucocutaneous Leishmaniasis
This study is currently recruiting participants.
Verified January 2011 by Paladin Labs (USA) Inc.
Sponsor:
Paladin Labs (USA) Inc.
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
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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:
- Is the subject a male or female at least 18 years of age?
- Does the subject weigh at least 30 kg?
- 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?
- In the opinion of the investigator, is the subject capable of understanding and complying with the protocol?
- 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?
- Has the patient signed informed consent?
Exclusion Criteria:
- Is the subject a female who is breast-feeding?
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
- 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
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 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antifungal Agents |
ClinicalTrials.gov processed this record on May 19, 2013