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

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ClinicalTrials.gov Identifier: NCT03876262
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Medicines Development for Global Health

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date February 28, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12 [ Time Frame: Up to 12 months ]
    Proportion of recipients with zero Onchocerca volvulus microfilariae/mg skin at all post-treatment timepoints to month 12
  • Incidence and severity of adverse events [ Time Frame: Up to 36 months ]
    Incidence and severity of adverse events, assessed by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • Proportion of participants in all dose groups with sustained microfilariae response [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months ]
    Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin
  • Sustained ocular microfilariae response in all dose groups [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months ]
    Proportion of participants with 0 live O. volvulus microfilariae in the anterior chambers of the eyes at all post-Baseline assessments in those with liver ocular microfilariae before the first treatment
  • Skin microfilarial density in all dose groups [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months ]
    Mean, median and percentage reduction Onchocerca volvulus microfilariae/mg skin from baseline
  • Proportion of participants in all dose groups with 0 Onchocerca volvulus microfilariae/mg skin and 0 live microfilariae in the anterior chambers of the eyes each timepoint [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 14, 2019)
  • Signs and symptoms of onchocerciasis in all dose groups [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months ]
    Proportion of participants with signs and symptoms of onchocerciasis with these signs and symptoms at baseline.
  • Viability and fertility of male and female macrofilariae in all dose groups [ Time Frame: 36 months ]
    Histopathological assessment of male and female macrofilariae excised from participants with palpable nodules
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
Official Title  ICMJE A Randomized, Double Blind, Parallel Trial in the Democratic Republic of Congo (DRC) Comparing the Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Treatment of Onchocerciasis
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be assigned to four groups: annual ivermectin; annual moxidectin; biannual ivermectin; or biannual moxidectin
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Onchocerciasis
Intervention  ICMJE
  • Drug: Moxidectin
    2mg tablets, encapsulated for blinding
  • Drug: Ivermectin
    3mg tablets, encapsulated for blinding
    Other Names:
    • Mectizan
    • Stromectol
Study Arms  ICMJE
  • Experimental: Annual Moxidectin
    Moxidectin 8mg per oral, administered annually for 24 months
    Intervention: Drug: Moxidectin
  • Experimental: Biannual Moxidectin
    Moxidectin 8mg per oral, administered biannually for 24 months
    Intervention: Drug: Moxidectin
  • Active Comparator: Annual Ivermectin
    Ivermectin (approximately) 150 micrograms/kg per oral, administered annually for 24 months
    Intervention: Drug: Ivermectin
  • Experimental: Biannual Ivermectin
    Ivermectin (approximately) 150 micrograms/kg per oral, administered biannually for 24 months
    Intervention: Drug: Ivermectin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of written informed consent, or assent with parental or guardian written consent
  • Mean ≥ 10 O. volvulus microfilariae/mg skin, determined by four skin snips
  • Living in a village selected for the study.
  • Age ≥ 12 years.
  • All female participants of childbearing potential who are not surgically sterile or post-menopausal must commit to the use of a reliable method of birth control for the duration of treatment and until 6 months after completion of dosing with investigational product (Month 30).

Exclusion Criteria:

  • Pregnant or breast-feeding.
  • Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health.
  • Has received ivermectin, oral diethylcarbamazine (DEC), doxycycline (for > 2 weeks) or suramin within 6 months of Screening.
  • Has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer).
  • Known or suspected allergy to ivermectin or moxidectin or their excipients.
  • Self-reported planned or ongoing activities within the study period that would make it unlikely that a participant will be available for all planned treatment rounds and follow-up examinations.
  • Weight ≥ 88 kg
  • Infection with Loa loa.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sally Kinrade +61396296111 sally.kinrade@medicinesdevelopment.com
Listed Location Countries  ICMJE Congo, The Democratic Republic of the
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03876262
Other Study ID Numbers  ICMJE MDGH-MOX-3001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Medicines Development for Global Health
Study Sponsor  ICMJE Medicines Development for Global Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tony Ukety, MD, DO, MPH Centre de Recherche en Maladies Tropicales de l'Ituri
PRS Account Medicines Development for Global Health
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP