Trial · NCT01050907
Miltefosine to Treat Mucocutaneous Leishmaniasis
NCT01050907, Phase 2, Completed, Knight Therapeutics (USA) Inc; results first posted 2020-09-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Miltefosine to Treat Mucocutaneous Leishmaniasis. Trials, record NCT01050907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01050907
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Miltefosine to Treat Mucocutaneous Leishmaniasis
- NCT number
- NCT01050907
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Knight Therapeutics (USA) Inc
- Conditions
- Mucosal Leishmaniasis, Cutaneous Leishmaniasis
- Interventions
- Miltefosine
- First posted
- 2010-01-18
- Last updated
- 2020-09-30
- Results first posted
- 2020-09-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Cure of Lesions | Week 6, Month 3, Month 7, and Month 13 | Percent of participants with clinical cure of all lesions. Ulcerated CL lesions were measured for the longest diameter and perpendicular width of ulceration; non-ulcerated lesions were measured for length and width of the raised area. A healed lesion was 100% reduction in lesion area (0x0); a cured lesion was a lesion healed at the Month 7 visit. For subjects with ML, an Ear, Nose, and Throat specialist examined the nasal and oral mucosa. Each site (nasal skin, nasal mucosa, palate, pharynx, larynx) was evaluated for signs of disease (erythema, edema, infiltration, erosion) and graded on a scale: 0=no disease, 1=mild disease, 2=moderate disease, 3=severe disease. Max score was 60 = poor outcome. Clinical response measured as a composite score, the mucosal severity score, which was the sum of the severity scores for each clinical sign at each clinical site of disease. A healed lesion had a score of 0 in absolute value (0% of the entrance score), and clinical cure was lesion is healed. |
| Primary | Number of Participants With Adverse Events | Up to 7 months for CL; Up to 13 months for ML | The number of participants with adverse events (AEs) by occurrence and severity. The Treating Physician monitored participants for the occurrence of AEs from the time the first investigational product was taken on Day 1 through the end of follow up at Month 7 for CL or Month 13 for ML. For the period between Study Day 1 and Study Week 6 (2 weeks after the end of therapy), all AEs regardless of seriousness or relationship to the investigational product were to be recorded on the case report form (CRF). For the period Week 6 to Month 7 for CL, or Month 13 for ML, only AEs requiring medical attention were recorded on the CRF. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Cure of Lesions | Week 6, Month 3, Month 7, and Month 13 | The evaluable population included all subjects who received daily doses of investigational product for at least 25 of the total of 28 days, had lesion measurements at Month 7 for cutaneous leishmaniasis or the month 13 visit for mucosal leishmaniasis, and who did not receive rescue medications to treat leishmaniasis at any time during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events | Up to 7 months for CL; Up to 13 months for ML | The safety population included all subjects who received any administration of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Cure of Lesions | Miltefosine | 3 | Participants | ||
| Number of Participants With Adverse Events | Miltefosine | 4 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Miltefosine | 4 | |
| Overall Study | COMPLETED | Miltefosine | 4 | |
| Overall Study | NOT COMPLETED | Miltefosine | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Epididymitis | Reproductive system and breast disorders | Miltefosine | 1 | 4 | 1 |
| other | Abdominal Pain Lower | Gastrointestinal disorders | Miltefosine | 1 | 4 | 1 |
| other | Nausea | Gastrointestinal disorders | Miltefosine | 2 | 4 | 7 |
| other | Vomiting | Gastrointestinal disorders | Miltefosine | 2 | 4 | 8 |
| other | Rash Pruritic | Skin and subcutaneous tissue disorders | Miltefosine | 1 | 4 | 1 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Miltefosine | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Miltefosine | 0 | 4 |
| Total, other adverse events | Miltefosine | 4 | 4 |
| Total, serious adverse events | Miltefosine | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01050907
GET https://conductscience.org/api/trials/v1/NCT01050907/registered