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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

Primary Purpose

Onchocerciasis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Moxidectin
Ivermectin
Albendazole
Sponsored by
Medicines Development for Global Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onchocerciasis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Provision of written informed consent, or assent with parental or guardian written consent
  • Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin
  • Living in an onchocerciasis endemic area.
  • Age ≥ 12 years.
  • All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3)

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 or oral diethylcarbamazine (DEC) within 30 days of Baseline.
  • Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
  • 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 the participant will be available for follow-up examinations.
  • Infection with Loa loa

Sites / Locations

  • Centre de Recherche pour les Maladies Tropicales NegligeesRecruiting
  • Centre Suisse de Recherches Scientifiques en Coˆte d'IvoireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Moxidectin

Ivermectin

Moxidectin with concomitant Albendazole

Ivermectin with concomitant Albendazole

Arm Description

In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0

In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0

In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 8 mg per oral with concomitant albendazole 400 mg per oral on Day 0

In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Ivermectin treatment with approximately 150 microgram/kilogram (μg/kg) per oral determined based on height with concomitant albendazole 400 mg per oral on Day 0

Outcomes

Primary Outcome Measures

Incidence and severity of treatment emergent adverse events
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.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2020
Last Updated
June 8, 2023
Sponsor
Medicines Development for Global Health
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1. Study Identification

Unique Protocol Identification Number
NCT04311671
Brief 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
Official Title
A Randomized, Double Blind, Parallel Group Clinical Trial to Evaluate the Safety 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 Treatment With Albendazole
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicines Development for Global Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onchocerciasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moxidectin
Arm Type
Experimental
Arm Description
In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0
Arm Title
Ivermectin
Arm Type
Active Comparator
Arm Description
In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0
Arm Title
Moxidectin with concomitant Albendazole
Arm Type
Experimental
Arm Description
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 8 mg per oral with concomitant albendazole 400 mg per oral on Day 0
Arm Title
Ivermectin with concomitant Albendazole
Arm Type
Active Comparator
Arm Description
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Ivermectin treatment with approximately 150 microgram/kilogram (μg/kg) per oral determined based on height with concomitant albendazole 400 mg per oral on Day 0
Intervention Type
Drug
Intervention Name(s)
Moxidectin
Intervention Description
2mg tablets, encapsulated for blinding
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Intervention Description
3mg tablets, encapsulated for blinding
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Description
400 mg tablets
Primary Outcome Measure Information:
Title
Incidence and severity of treatment emergent adverse events
Description
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.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent, or assent with parental or guardian written consent Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin Living in an onchocerciasis endemic area. Age ≥ 12 years. All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3) 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 or oral diethylcarbamazine (DEC) within 30 days of Baseline. Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration. Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high lymphatic filariasis co-endemicity requiring concomitant albendazole administration, known or suspected allergy to albendazole and its excipients. Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations. Infection with Loa loa
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Kinrade
Phone
+61 3 9912 2411
Email
sally.kinrade@medicinesdevelopment.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mupenzi Mumbere
Phone
+61 3 9912 2428
Email
mupenzi.mumbere@medicinesdevelopment.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Ukety, MD, DO, MPH
Organizational Affiliation
Centre de Recherche en Maladies Tropicales de l'Ituri
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin Koudou, PhD
Organizational Affiliation
Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche pour les Maladies Tropicales Negligees
City
Rethy
State/Province
Ituri
Country
Congo, The Democratic Republic of the
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Ukety, MD, DO, MPH
Facility Name
Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
City
Abidjan
Country
Côte D'Ivoire
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Koudou, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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