A Phase 2 interventional study of Moxidectin Oral Product in Scabies, sponsored by Medicines Development for Global Health. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Medicines Development for Global Health · Phase 2, Interventional, and Treatment
The effective dose of moxidectin to treat human scabies is not known. This study aims to provide proof of concept that a single dose of moxidectin is effective in eliminating the scabies parasite in humans and to enable the determination of an optimal dose of moxidectin for treatment of scabies for further clinical studies.
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 22 is below the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →Medicines Development for Global Health is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Clinically relevant laboratory abnormalities at Screening, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Moxidectin 2 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.
Drug: Moxidectin Oral Product
Moxidectin 8 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.
Drug: Moxidectin Oral Product
Moxidectin 20 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.
Drug: Moxidectin Oral Product
Moxidectin 36 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.
Drug: Moxidectin Oral Product
The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required
Mortality Rate for Adult Scabies Mites
Adult scabies mite death was based on the reflectance confocal microscopy (RCM) morphology assessment of 2 live adult scabies mites nominated pre-treatment (Baseline), hence overall number of units analyzed are different from the overall number of participants. For the outcome measure, the number of adult mites assessed at each timepoint is the sum of the number of adult mites from all participants in the analysis population for each dose. Therefore, mortality was assessed in 2 mites in the 2 mg group, 6 in the 8 mg group, 8 in the 20 mg group and 14 in the 32 mg group. Adult mite death was defined as the degradation (homogenization of internal structures and/or external anatomic structures, and increased reflectance) of the adult mite observed by RCM. The number of dead mites was assessed at Hours 4, 8, 24, 48 and 72, and Days 7, 14 and 28 compared to the baseline adult mites.
Time frame: 28 days
Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set)
No formal statistical analysis of AEs was undertaken. Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of Investigational Product (Moxidectin). Moxidectin was generally well tolerated, with no treatment-related SAEs reported and no treatment emergent adverse event (TEAEs) leading to study withdrawal or resulting in death. Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term. Data up to and including the Day 28 assessment for each subject.
Time frame: Day 0 to Day 28 inclusive
Number of Participants and Severity of Adverse Events
Number of participants with Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of IP. Data up to and including the Day 28 assessment for each subject. The severity of adverse events were assessed using the Toxicity Grading Scale for Healthy Adult and Adolescent volunteers Enrolled in Preventive Vaccine Clinical Trials.
Time frame: Day 0 to Day 28 inclusive
Analysis of Moxidectin Plasma Concentrations
The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL).
Time frame: Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h)
Analysis of Moxidectin Maximum Plasma Concentrations (Cmax)
The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL).
Time frame: Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h)
Incidence and Severity of Scabies Signs and Symptoms
The incidence and severity of signs and symptoms of scabies infection will be explored using a clinician-reported scabies severity assessment.
Time frame: 28 days
Severity of Pruritus
The severity of pruritus will be determined using the Numerical Rating Scale where 0="no itch" and 10="worst itch imaginable"
Time frame: 28 days
The study was open to recruitment on 13 Jan 2020 and the First participant was screened on 15 Jan 2020. Last participant last study visit was completed on 28 Feb 2022.
| Milestone | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg |
|---|---|---|---|---|
| Started | 4 | 4 | 6 | 8 |
| Completed | 3 | 3 | 6 | 8 |
| Not completed | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 |
Adult scabies mite death was based on the reflectance confocal microscopy (RCM) morphology assessment of 2 live adult scabies mites nominated pre-treatment (Baseline), hence overall number of units analyzed are different from the overall number of participants. For the outcome measure, the number of adult mites assessed at each timepoint is the sum of the number of adult mites from all participants in the analysis population for each dose. Therefore, mortality was assessed in 2 mites in the 2 mg group, 6 in the 8 mg group, 8 in the 20 mg group and 14 in the 32 mg group. Adult mite death was defined as the degradation (homogenization of internal structures and/or external anatomic structures, and increased reflectance) of the adult mite observed by RCM. The number of dead mites was assessed at Hours 4, 8, 24, 48 and 72, and Days 7, 14 and 28 compared to the baseline adult mites.
| Adult mites | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg |
|---|---|---|---|---|
| Number of live adult mites assessed at Baseline | 2 | 6 | 8 | 14 |
| Number of dead adult mites assessed at Day 0-4 hours timepoint | 0 | 0 | 0 | 0 |
| Number of dead adult mites assessed at Day 0-8 hours timepoint | 0 | 1 | 0 | 0 |
| Number of dead adult mites assessed at Day 1 timepoint | 0 | 2 | 0 | 0 |
| Number of dead adult mites assessed at Day 2 timepoint | 0 | 2 | 1 | 2 |
| Number of dead adult mites assessed at Day 3 timepoint | 0 | 2 | 2 | 3 |
| Number of dead adult mites assessed at Day 7 timepoint | 0 | 4 | 4 | 9 |
| Number of dead adult mites assessed at Day 14 timepoint | 0 | 5 | 8 | 12 |
| Number of dead adult mites assessed at Day 28 timepoint | 0 | 6 | 8 | 14 |
No formal statistical analysis of AEs was undertaken. Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of Investigational Product (Moxidectin). Moxidectin was generally well tolerated, with no treatment-related SAEs reported and no treatment emergent adverse event (TEAEs) leading to study withdrawal or resulting in death. Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term. Data up to and including the Day 28 assessment for each subject.
| Participants | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg |
|---|---|---|---|---|
| Infections and infestations | 3 | 3 | 5 | 5 |
| Skin and subcutaneous tissue disorder | 1 | 2 | 1 | 4 |
| Nervous system disorders | 2 | 0 | 1 | 3 |
| Psychiatric disorders | 2 | 0 | 1 | 0 |
| Gastrointestinal disorders | 0 | 1 | 1 | 0 |
Number of participants with Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of IP. Data up to and including the Day 28 assessment for each subject. The severity of adverse events were assessed using the Toxicity Grading Scale for Healthy Adult and Adolescent volunteers Enrolled in Preventive Vaccine Clinical Trials.
| Participants | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg |
|---|---|---|---|---|
| Grade 1 TEAEs | 1 | 1 | 4 | 5 |
| Grade 2 TEAEs | 3 | 3 | 2 | 3 |
| Grade 3 TEAEs | 0 | 0 | 0 | 0 |
| Grade 4 TEAEs | 0 | 0 | 0 | 0 |
The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL).
| hr*ng/mL | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg |
|---|---|---|---|---|
| AUC0-24 (hr*ng/mL) | 181 ± 43.2 | 744 ± 37.9 | 1670 ± 40.2 | 2930 ± 26.8 |
| AUC0-48 (hr*ng/mL) | 212 ± 44.2 | 903 ± 35.0 | 2000 ± 40.7 | 3560 ± 29.3 |
| AUC0-72 (hr*ng/mL) | 229 ± 45.5 | 989 ± 33.7 | 2200 ± 40.4 | 3900 ± 31.0 |
| AUC0-D7 (hr*ng/mL) | 276 ± 50.6 | 1230 ± 30.5 | 2780 ± 39.5 | 4770 ± 35.1 |
| AUC0-D14 (hr*ng/mL) | 329 ± 62.8 | 1540 ± 27.9 | 3530 ± 39.3 | 5820 ± 38.1 |
| AUC0-D28 (hr*ng/mL) | 408 ± 82.5 | 1970 ± 30.0 | 4670 ± 41.1 | 7430 ± 37.6 |
The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL).
| Cmax (ng/mL) | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg |
|---|---|---|---|---|
| Analysis of Moxidectin Maximum Plasma Concentrations (Cmax) | 21.0 ± 47.1 | 73.5 ± 42.0 | 207 ± 44.9 | 277 ± 26.9 |
The incidence and severity of signs and symptoms of scabies infection will be explored using a clinician-reported scabies severity assessment.
Results for this outcome have not been posted.
The severity of pruritus will be determined using the Numerical Rating Scale where 0="no itch" and 10="worst itch imaginable"
Results for this outcome have not been posted.
Collected over Day 0 to Week 12, inclusive.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moxidectin 2 mg | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Moxidectin 8 mg | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Moxidectin 20 mg | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Moxidectin 36 mg | 0/8 (0%) | 1/8 (12.5%) | 8/8 (100%) |
| Event | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg |
|---|---|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/4 | 0/4 | 0/6 | 1/8 |
| Uterine haemorrhageReproductive system and breast disorders | 0/4 | 0/4 | 0/6 | 1/8 |
| Event | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg |
|---|---|---|---|---|
| AcarodermatitisInfections and infestations | 2/4 | 3/4 | 4/6 | 5/8 |
| EczemaSkin and subcutaneous tissue disorders | 0/4 | 2/4 | 0/6 | 1/8 |
| PruritusSkin and subcutaneous tissue disorders | 0/4 | 0/4 | 1/6 | 3/8 |
| HeadacheNervous system disorders | 1/4 | 0/4 | 1/6 | 2/8 |
| DiarrhoeaGastrointestinal disorders | 0/4 | 1/4 | 1/6 | 0/8 |
| NauseaGastrointestinal disorders | 0/4 | 1/4 | 1/6 | 0/8 |
| Rash papularSkin and subcutaneous tissue disorders | 1/4 | 0/4 | 0/6 | 1/8 |
| InsomniaPsychiatric disorders | 1/4 | 0/4 | 1/6 | 0/8 |
| Urinary tract infectionInfections and infestations | 1/4 | 0/4 | 0/6 | 0/8 |
| PresyncopeNervous system disorders | 1/4 | 0/4 | 0/6 | 0/8 |
Analysis Population is all enrolled subjects.
| Age, Categorical(Participants) | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 | 7 | 19 |
| >=65 years | 1 | 1 | 0 | 1 | 3 |
| Age, Continuous(years) | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg | Total |
|---|---|---|---|---|---|
| Mean | 46.5 ± 18.88 | 45.3 ± 15.50 | 27.2 ± 9.33 | 29.4 ± 17.26 | 34.8 ± 16.73 |
| Sex: Female, Male(Participants) | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg | Total |
|---|---|---|---|---|---|
| Female | 4 | 1 | 4 | 4 | 13 |
| Male | 0 | 3 | 2 | 4 | 9 |
| Race (NIH/OMB)(Participants) | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 2 | 3 | 4 | 8 | 17 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 2 | 0 | 5 |
| Body Mass Index(kg/m^2) | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 20 mg | Moxidectin 36 mg | Total |
|---|---|---|---|---|---|
| Mean | 32.98 ± 9.95 | 25.27 ± 2.40 | 21.70 ± 2.31 | 28.68 ± 8.46 | 27.01 ± 7.68 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2020 to primary completion in Feb 2022, 25 months.
Results were first posted in Sep 2023, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Moxidectin
Medicines Development for Global Health