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Trial record 37 of 50 for:    "Elephantiasis" | "Anti-Infective Agents"

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 : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Medicines Development Limited

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.


Condition or disease Intervention/treatment Phase
Onchocerciasis Drug: Moxidectin Drug: Ivermectin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
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
Official Title: 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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023


Arm Intervention/treatment
Experimental: Annual Moxidectin
Moxidectin 8mg per oral, administered annually for 24 months
Drug: Moxidectin
2mg tablets, encapsulated for blinding

Experimental: Biannual Moxidectin
Moxidectin 8mg per oral, administered biannually for 24 months
Drug: Moxidectin
2mg tablets, encapsulated for blinding

Active Comparator: Annual Ivermectin
Ivermectin (approximately) 150 micrograms/kg per oral, administered annually for 24 months
Drug: Ivermectin
3mg tablets, encapsulated for blinding
Other Names:
  • Mectizan
  • Stromectol

Experimental: Biannual Ivermectin
Ivermectin (approximately) 150 micrograms/kg per oral, administered biannually for 24 months
Drug: Ivermectin
3mg tablets, encapsulated for blinding
Other Names:
  • Mectizan
  • Stromectol




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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 ]

Other Outcome Measures:
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876262


Contacts
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Contact: Sally Kinrade +61396296111 sally.kinrade@medicinesdevelopment.com

Locations
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Congo, The Democratic Republic of the
Centre de Recherche pour les Maladies Tropicales Negligees Not yet recruiting
Rethy, Ituri, Congo, The Democratic Republic of the
Contact: Tony Ukety         
Sponsors and Collaborators
Medicines Development Limited
Investigators
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Principal Investigator: Tony Ukety, MD, DO, MPH Centre de Recherche en Maladies Tropicales de l'Ituri

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Responsible Party: Medicines Development Limited
ClinicalTrials.gov Identifier: NCT03876262     History of Changes
Other Study ID Numbers: MDGH-MOX-3001
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Filariasis
Anti-Infective Agents
Onchocerciasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Ivermectin
Milbemycin
Antiparasitic Agents
Anthelmintics
Antinematodal Agents