Trial · NCT04311671
Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole
NCT04311671, Phase 3, Completed, Medicines Development for Global Health; results first posted 2026-02-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole. Trials, record NCT04311671. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04311671
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole
- NCT number
- NCT04311671
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 12,979 participants, actual
- Lead sponsor
- Medicines Development for Global Health
- Conditions
- Onchocerciasis
- Interventions
- Moxidectin, Ivermectin, Albendazole
- First posted
- 2020-03-17
- Last updated
- 2026-03-03
- Results first posted
- 2026-02-05
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and Severity of Treatment Emergent Adverse Events | Up to 3 months | Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence and Severity of Treatment Emergent Adverse Events | Up to 3 months | Participants who received a single dose of moxidectin or ivermectin and participants who received a single dose of moxidectin or ivermectin with albendazole analyzed separately by endemic area and pooled. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence and Severity of Treatment Emergent Adverse Events | Moxidectin | Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs) | 346 | participants | |
| Incidence and Severity of Treatment Emergent Adverse Events | Ivermectin | Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs) | 79 | participants | |
| Incidence and Severity of Treatment Emergent Adverse Events | Moxidectin Plus Albendazole | Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs) | 1199 | participants | |
| Incidence and Severity of Treatment Emergent Adverse Events | Ivermectin Plus Albendazole | Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs) | 288 | participants | |
| Incidence and Severity of Treatment Emergent Adverse Events | Moxidectin +/- Albendazole (Pooled) | Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs) | 1545 | participants | |
| Incidence and Severity of Treatment Emergent Adverse Events | Ivermectin +/- Albendazole (Pooled) | Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs) | 367 | participants | |
| Incidence and Severity of Treatment Emergent Adverse Events | Moxidectin | Number of Participants with one or more TEAEs defined as a Mazzotti Reaction | 173 | participants | |
| Incidence and Severity of Treatment Emergent Adverse Events | Ivermectin | Number of Participants with one or more TEAEs defined as a Mazzotti Reaction | 47 | participants | |
| Incidence and Severity of Treatment Emergent Adverse Events | Moxidectin Plus Albendazole | Number of Participants with one or more TEAEs defined as a Mazzotti Reaction | 455 | participants | |
| Incidence and Severity of Treatment Emergent Adverse Events | Ivermectin Plus Albendazole | Number of Participants with one or more TEAEs defined as a Mazzotti Reaction | 98 | participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Moxidectin | 6,421 | |
| Overall Study | STARTED | Ivermectin | 1,605 | |
| Overall Study | STARTED | Moxidectin Plus Albendazole | 3,959 | |
| Overall Study | STARTED | Ivermectin Plus Albendazole | 994 | |
| Overall Study | COMPLETED | Moxidectin | 6,395 | |
| Overall Study | COMPLETED | Ivermectin | 1,592 | |
| Overall Study | COMPLETED | Moxidectin Plus Albendazole | 3,891 | |
| Overall Study | COMPLETED | Ivermectin Plus Albendazole | 977 | |
| Overall Study | NOT COMPLETED | Moxidectin | 26 | |
| Overall Study | NOT COMPLETED | Ivermectin | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events438
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 | Tachycardia or Palpitations | Cardiac disorders | Moxidectin | 5 | 6,421 | 5 |
| other | Tachycardia or Palpitations | Cardiac disorders | Ivermectin | 1 | 1,605 | 1 |
| other | Tachycardia or Palpitations | Cardiac disorders | Moxidectin Plus Albendazole | 7 | 3,959 | 7 |
| other | Tachycardia or Palpitations | Cardiac disorders | Ivermectin Plus Albendazole | 2 | 994 | 2 |
| other | Tachycardia or Palpitations | Cardiac disorders | Moxidectin +/- Albendazole (Pooled) | 12 | 10,380 | 12 |
| other | Tachycardia or Palpitations | Cardiac disorders | Ivermectin +/- Albendazole (Pooled) | 3 | 2,599 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Moxidectin | 4 | 6,421 | 4 |
| other | Vertigo | Ear and labyrinth disorders | Ivermectin | 1 | 1,605 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Moxidectin Plus Albendazole | 2 | 3,959 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Ivermectin Plus Albendazole | 1 | 994 | 1 |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Moxidectin | 6 | 6,421 |
| Total, all-cause mortality | Ivermectin | 2 | 1,605 |
| Total, all-cause mortality | Moxidectin Plus Albendazole | 3 | 3,959 |
| Total, all-cause mortality | Ivermectin Plus Albendazole | 0 | 994 |
| Total, all-cause mortality | Moxidectin +/- Albendazole (Pooled) | 9 | 10,380 |
| Total, all-cause mortality | Ivermectin +/- Albendazole (Pooled) | 2 | 2,599 |
| Total, other adverse events | Moxidectin | 346 | 6,421 |
| Total, other adverse events | Ivermectin | 79 | 1,605 |
| Total, other adverse events | Moxidectin Plus Albendazole | 1,199 | 3,959 |
| Total, other adverse events | Ivermectin Plus Albendazole | 288 | 994 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT04311671
GET https://conductscience.org/api/trials/v1/NCT04311671/results?page=2