LeishmaniasisPhase 2NCT01377974
Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis
A Phase 2 study testing Miltefosine and Standard Treatment Meglumine antimoniate in people with Leishmaniasis and Leishmaniasis, Mucocutaneous, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment. Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Leishmaniasis, Leishmaniasis, Mucocutaneous
- What is being tested?
- Miltefosine and Standard Treatment Meglumine antimoniate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of mucosal leishmaniasis
- Not previously treated, or last treatment must have occurred more than 6 months before the enrollment on the study
- Use of contraceptive method, if female on child bearing age
- Sign the agreement and consent form
Who cannot join
- Previous leishmanicidal treatment on the past 6 months before the enrollment on the study
- Electrocardiogram abnormalities on the pretreatment exams
- Previous kidney, liver and/or heart diseases
- Diabetes Mellitus
- Hypersensitivity to miltefosine or meglumine antimoniate
- Pregnant women or breastfeeding mothers
- Hiv patients
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Brasilia University Hospital
Brasília, Federal District, 70910-900
About this study
Official title: Randomized Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis at Federal District, Brazil
The purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.
Read the detailed description
Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not treated. It is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. Also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. The standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South American countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard treatment have being done.
- Conditions
- Leishmaniasis, Leishmaniasis, Mucocutaneous
- Being tested
- Miltefosine, Standard Treatment Meglumine antimoniate
- Keywords
- Leishmaniasis, Mucocutaneous Leishmaniasis, Therapeutics, meglumine antimoniate, miltefosine
- Medical subject headings
- Leishmaniasis, Leishmaniasis, Mucocutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiltefosineDrug
Also called Impavido
1 Capsule of 50mg, taken orally 2 times a day for 28 days
Standard Treatment Meglumine antimoniateDrug
Also called pentavalent antimonial
20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Meglumine antimoniate as recommended by the Brazilian Ministry of Health Receives: Drug: Standard Treatment Meglumine antimoniate |
| Tested Intervention | Experimental | Miltefosine as the tested intervention Receives: Drug: Miltefosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure
Re-epithelizations of mucosal ulcers or regression of symptoms
Measured: 6 months
Secondary outcomes (1)
Adverse effects
laboratory tests of blood, kidney, liver and cardiac functions, partients will be asked about nausea, vomiting, diarrhea, myalgia, or other symptoms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJul 2009
- Primary completionJun 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Silva, Brasilia University Hospital
- Investigators
- Juliana SF Silva, MD, Principal investigator, University of BrasiliaRaimunda NR Sampaio, PhD, Study chair, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377974
- Sponsor's protocol ID
- MILTHUB
- Status last verified
- Jun 2015
- First submitted
- 20 Jun 2011
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis at Federal District, Brazil
- ClinicalTrials.gov ID
- NCT01377974
- Acronym / sponsor ID
- MILTHUB
- Conditions
- Leishmaniasis, Leishmaniasis, Mucocutaneous
- Keywords
- Leishmaniasis, Mucocutaneous Leishmaniasis, Therapeutics, meglumine antimoniate, miltefosine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.
Detailed description
Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not treated. It is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. Also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. The standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South American countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard treatment have being done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Drug: Standard Treatment Meglumine antimoniateMeglumine antimoniate as recommended by the Brazilian Ministry of Health |
| Tested Intervention | Experimental | Drug: MiltefosineMiltefosine as the tested intervention |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of mucosal leishmaniasis
- Not previously treated, or last treatment must have occurred more than 6 months before the enrollment on the study
- Use of contraceptive method, if female on child bearing age
- Sign the agreement and consent form
Key exclusion criteria (7 listed)
- Previous leishmanicidal treatment on the past 6 months before the enrollment on the study
- Electrocardiogram abnormalities on the pretreatment exams
- Previous kidney, liver and/or heart diseases
- Diabetes Mellitus
- Hypersensitivity to miltefosine or meglumine antimoniate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiltefosineAlso: Impavido1 Capsule of 50mg, taken orally 2 times a day for 28 days | Drug | Tested Intervention |
| Standard Treatment Meglumine antimoniateAlso: pentavalent antimonial20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health | Drug | Standard Treatment |
Primary outcome
Cure
Time frame: 6 months
Re-epithelizations of mucosal ulcers or regression of symptoms
1 secondary outcome
Adverse effects
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana SF Silva, MD principal investigator
University of Brasilia
Raimunda NR Sampaio, PhD study chair
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miltefosine and Standard Treatment Meglumine antimoniate in people with Leishmaniasis and Leishmaniasis, Mucocutaneous, run by Brasilia University Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.