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Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Study completion date: Jul 2026 to Jan 1, 2026v17
  2. Re-verified, no change to tracked fieldsv16
  3. Primary completion date changed from estimate of Jul 2024 to Jul 31, 2024v15
  4. Trial status: Recruiting to Active, Not Recruitingv14 Show 4 more changesShow less
    • Enrollment target: estimated 320 to confirmed 323
    • Primary completion date: May 2024 to Jul 2024
    • Study completion date: Aug 2026 to Jul 2026
    • Site details revised
  5. Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Enrollment target: 1000 to 320v12
  2. 2 versions Re-verified since Feb 6, 2023, no change to tracked fieldsv10-v11
  3. Primary completion date: Jul 2022 to May 2024
    • Study completion date: Jul 2024 to Aug 2026
    v9
  4. 2 versions Re-verified since Sep 29, 2021, no change to tracked fieldsv7-v8
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2021 to May 3, 2021
    • Site details revised
    v6
  6. Start date: Feb 2021 to Mar 2021v5
  7. Primary completion date: Nov 2023 to Jul 2022
    • Start date: Nov 2020 to Feb 2021
    • Study completion date: Nov 2023 to Jul 2024
    v4
  8. Start date: Aug 2020 to Nov 2020
    • Primary and study completion dates: Oct 2023 to Nov 2023
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 4 to 5
    v3
  9. Primary and study completion dates: Mar 2023 to Oct 2023
    • Start date: Nov 2019 to Aug 2020
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O. volvulus microfilaria in skin, the parasite that causes river blindness. Secondary purposes are to determine the effectiveness of moxidectin compared to ivermectin once or twice a year in maintaining undetectable levels, or reducing levels, of skin microfilaria.
Trial Details
NCT Number NCT03876262
Lead Sponsor Medicines Development for Global Health
Conditions
(from sponsor)		 Onchocerciasis
Related terms Onchocerciasis
Enrollment 323 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov