11 completed, 2 unknown, 1 not yet recruiting. 14 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 14 | Completed 11, Unknown 2, Not yet recruiting 1 |
| Phase 2 | 2 | Completed 1, Unknown 1 |
Follow miltefosine: new trials by email Literature Review of miltefosine trials Research Report on miltefosine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) Sodium Stibogluconate (SSG), Miltefosine, Miltefosine + Paromomycin - Cutaneous Leihmaniasis | Phase 3 | Not yet recruiting | Institute of Tropical Medicine, Belgium | 900 | 2027-01-01 | 2026-03-10 |
| Randomised Clinical Trial in Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan drug: miltefosine with thermotherapy - Old World Cutaneous Leishmaniasis | Phase 3 | Completed | Medecins Sans Frontieres, Netherlands | 645 | 2022-10-07 | 2026-07-30 |
| Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly Miltefosine 50mg, Pentoxifylline 400mg, Liposomal Amphotericin B - Leishmaniasis; Brazilian, Leishmaniasis, Mucocutaneous | Phase 2 / Phase 3 | Unknown | University of Brasilia | 100 | 2022-06-22 | 2023-09-15 |
| Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World Meglumine Antimoniate, Miltefosine, Thermotherapy machine - Cutaneous Leishmaniases | Phase 3 | Completed | Drugs for Neglected Diseases | 184 | 2021-01-26 | 2025-05-08 |
| Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis Miltefosine and Paromomycin, miltefosine, paromomycin - Cutaneous Leishmaniasis, American | Phase 2 / Phase 3 | Completed | Fundacion Nacional de Dermatologia | 120 | 2019-02-01 | 2021-02-02 |
| Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa Miltefosine, Paromomycin, Sodium stibogluconate - Visceral Leishmaniasis | Phase 3 | Completed | Drugs for Neglected Diseases | 439 | 2018-01-24 | 2024-02-29 |
| Miltefosine and GM-CSF in Cutaneous Leishmaniasis Sbv, Miltefosine plus placebo, Miltefosine plus GM-CSF - Cutaneous Leishmaniasis | Phase 3 | Completed | Hospital Universitário Professor Edgard Santos | 300 | 2017-06-30 | 2020-04-07 |
| Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients. Liposomal Amphotericin B, Miltefosine - Visceral Leishmaniasis | Phase 3 | Completed | Drugs for Neglected Diseases | 59 | 2014-07-01 | 2019-04-08 |
| Miltefosine for Children With PKDL Miltefosine - Post Kala Azar Dermal Leishmaniasis | Phase 3 | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | 80 | 2014-07-01 | 2019-08-21 |
| Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh Liposomal amphotericin B, liposomal amphotericin B + miltefosine, liposomal amphotericin B + paromomycin - Visceral Leishmaniasis | Phase 3 | Completed | Drugs for Neglected Diseases | 602 | 2010-05-01 | 2016-01-21 |
| Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis Amphotericin B Deoxycholate, Ambisome + Miltefosine, Ambisome and Paromomycin - Visceral Leishmaniasis | Phase 3 | Completed | Drugs for Neglected Diseases | 634 | 2008-06-01 | 2010-02-11 |
| Combination Therapy in Indian Visceral Leishmaniasis amphotericin B deoxycholate, Liposomal Amphotericin B with Miltefosine, Liposomal Amphotericin B and Paromomycin Sulfate - Leishmaniasis, Visceral | Phase 3 | Completed | Banaras Hindu University | 624 | 2007-09-01 | 2010-05-26 |
| Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia Miltefosine, Meglumine antimoniate - Cutaneous Leishmaniasis | Phase 3 | Unknown | Centro Internacional de Entrenamiento e Investigaciones Médicas | 150 | 2007-07-01 | 2010-02-17 |
| Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia. Miltefosine, Thermotherapy, Glucantime® - Cutaneous Leishmaniasis | Phase 3 | Completed | Universidad de Antioquia | 437 | 2006-06-01 | 2019-01-16 |
Leishmaniasis, Cutaneous (6) · Leishmaniasis, Visceral (6) · Hyperthermia (2) · Leishmaniasis (2) · Leishmaniasis, Mucocutaneous (2)
Drugs for Neglected Diseases (5) · Banaras Hindu University (1) · Centro Internacional de Entrenamiento e Investigaciones Médicas (1) · Fundacion Nacional de Dermatologia (1) · Hospital Universitário Professor Edgard Santos (1) · Institute of Tropical Medicine, Belgium (1) · International Centre for Diarrhoeal Disease Research, Bangladesh (1) · Medecins Sans Frontieres, Netherlands (1) · Universidad de Antioquia (1) · University of Brasilia (1)
Brazil (3) · Ethiopia (3) · Bangladesh (2) · Bolivia (2) · India (2) · Colombia (1) · Kenya (1) · Pakistan (1) · Panama (1) · Peru (1) · Sudan (1) · Uganda (1)
Ahmed M Musa, MD, Prof (1) · Edgar M Carvalho, MD, PhD (1) · Ermias Diro, Dr. MD (1) · Farrokh Modabber (1) · Fiorela Yuly Alvarez Romero (1) · Gerson Penna, MD, PhD (1) · Glaucia Cota (1) · Jaime Soto (1) · Jane Mbui, MD (1) · Johan Van Griensven (1) · Joseph Olobo, MD, Prof (1) · Juan Miguel Pascale (1) · Koert Ritmeijer (1)
PMID 21255828, PMID 22238470, PMID 22594858, PMID 23740007, PMID 27188804, PMID 28379954, PMID 28558062, PMID 30653490, PMID 30789910, PMID 32894278, PMID 33253864, PMID 36164254