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Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

Primary Purpose

Onchocerciasis

Status
Completed
Phase
Phase 2
Locations
Ghana
Study Type
Interventional
Intervention
2 mg moxidectin
ivermectin 150 mcg/kg
4 mg moxidectin
8 mg moxidectin
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 focused on measuring onchocerciasis, onchocerca volvulus, river blindness, ivermectin, moxidectin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written, signed (or thumb-printed), and dated informed consent Aged 18 to 60 years, inclusive Body weight ≥ 40 kg for women and ≥ 45 kg for men Nonpregnant, nonbreastfeeding women. Women of child bearing potential must agree to use birth control during the first 150 days after treatment. Healthy, as determined by a physician on the basis of a physical examination, ECG, and a thorough review of the medical history and clinical laboratory results Adequate hematologic, renal, and hepatic function Skin microfilarial density within the required range for the cohort Exclusion Criteria: Participation in any studies other than purely observational ones, within 4 weeks before test article administration. Any vaccination within 4 weeks before test article administration Acute infection requiring therapy within the last 10 days before test article administration Administration of any medication (with the exception of medication required to treat any reactions during the screening fluorescein angiography (chlorpheniramine) or paracetamol) or herbal preparation within 10 days prior to test article administration or any condition currently requiring regular medication Clinically significant ECG abnormalities or history of cardiac abnormality Past or current history of neurological or neuropsychiatric disease or epilepsy Subjects with orthostatic hypotension at the screening evaluation History of drug or alcohol abuse or regular use of ≥ 3 cigarettes per day Use of alcohol or other drugs of abuse within 72 hours before test article administration Any condition, in the investigator's opinion, that places the subject at undue risk Subjects who have donated blood within 8 weeks before study entry Subjects with ocular onchocerciasis in cohorts intended to enroll subjects with mild infection. Ocular onchocerciasis is defined by the presence of live or dead microfilariae, onchocercal punctate opacities, onchocercal lesions of the posterior segment or lesions that mimic those seen in onchocerciasis. Subjects with hyperreactive onchodermatitis Antifilarial therapy within the previous 5 years Coincidental infection with Loa Loa Female subjects of childbearing potential with a contraindication to DMPA if not on Norplant Any other condition which the investigator feels would exclude the subject from the study

Sites / Locations

  • Onchocerciasis Chemotherapy Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

2 mg moxidectin

Ivermectin 150 mcg/kg

4 mg moxidectin

8 mg moxidectin

Arm Description

2 mg moxidectin (Dose-escalation 1st step)

Active comparator arm (ivermectin 150 mcg/kg).

4 mg moxidectin (dose escalation second step)

8 mg moxidectin (dose escalation third step)

Outcomes

Primary Outcome Measures

Incidence of clinical adverse events and clinically significant laboratory test results

Secondary Outcome Measures

Skin mf counts at day 8 and months 1, 2, 3, 6, 12 and 18
Nodulectomy at 18 months
Pharmacokinetics (PKs) at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12

Full Information

First Posted
March 7, 2006
Last Updated
December 13, 2022
Sponsor
Medicines Development for Global Health
Collaborators
World Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00300768
Brief Title
Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection
Official Title
A Randomized, Single-Ascending Dose, Ivermectin-Controlled, Double-Blind, Safety, Tolerability, Pharmacokinetic, and Efficacy Study Of Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 6, 2006 (Actual)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 29, 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this study was to determine the safety and tolerability of moxidectin in subjects infected with Onchocerca volvulus (a parasitic worm).
Detailed Description
This was a phase 2, randomized, ivermectin-controlled, double-blind, single-ascending-dose, parallel design, inpatient/outpatient study of moxidectin administered to subjects of both sexes with different degrees of severity of O. volvulus infection. The study was conducted at a single site in Ghana. Secondary objects are to determine the pharmacokinetics of moxidectin, to obtain initial indication of the efficacy in terms of long term effect on skin microfilaria levels and an indication of the effect on the macrofilaria that may underlie the effect on skin microfilaria levels. Subjects were enrolled in consecutive cohorts to receive a single oral dose of 2 mg, 4 mg or 8 mg or moxidectin or ivermectin 150 µg/kg by severity of infection, based on the mean of the skin microfilariae densities at each of 4 body locations, both iliac crests and calves.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onchocerciasis
Keywords
onchocerciasis, onchocerca volvulus, river blindness, ivermectin, moxidectin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 mg moxidectin
Arm Type
Experimental
Arm Description
2 mg moxidectin (Dose-escalation 1st step)
Arm Title
Ivermectin 150 mcg/kg
Arm Type
Active Comparator
Arm Description
Active comparator arm (ivermectin 150 mcg/kg).
Arm Title
4 mg moxidectin
Arm Type
Experimental
Arm Description
4 mg moxidectin (dose escalation second step)
Arm Title
8 mg moxidectin
Arm Type
Experimental
Arm Description
8 mg moxidectin (dose escalation third step)
Intervention Type
Drug
Intervention Name(s)
2 mg moxidectin
Intervention Description
Single-dose, tablet encapsulated for blinding
Intervention Type
Drug
Intervention Name(s)
ivermectin 150 mcg/kg
Intervention Description
Single-dose, tablets encapsulated for blinding
Intervention Type
Drug
Intervention Name(s)
4 mg moxidectin
Intervention Description
Single dose, tablets encapsulated for blinding
Intervention Type
Drug
Intervention Name(s)
8 mg moxidectin
Intervention Description
single dose, tablets encapsulated for blinding
Primary Outcome Measure Information:
Title
Incidence of clinical adverse events and clinically significant laboratory test results
Time Frame
Duration of follow up (18 months)
Secondary Outcome Measure Information:
Title
Skin mf counts at day 8 and months 1, 2, 3, 6, 12 and 18
Time Frame
day 8 and months 1, 2, 3, 6, 12, 18
Title
Nodulectomy at 18 months
Time Frame
18 months
Title
Pharmacokinetics (PKs) at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12
Time Frame
days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written, signed (or thumb-printed), and dated informed consent Aged 18 to 60 years, inclusive Body weight ≥ 40 kg for women and ≥ 45 kg for men Nonpregnant, nonbreastfeeding women. Women of child bearing potential must agree to use birth control during the first 150 days after treatment. Healthy, as determined by a physician on the basis of a physical examination, ECG, and a thorough review of the medical history and clinical laboratory results Adequate hematologic, renal, and hepatic function Skin microfilarial density within the required range for the cohort Exclusion Criteria: Participation in any studies other than purely observational ones, within 4 weeks before test article administration. Any vaccination within 4 weeks before test article administration Acute infection requiring therapy within the last 10 days before test article administration Administration of any medication (with the exception of medication required to treat any reactions during the screening fluorescein angiography (chlorpheniramine) or paracetamol) or herbal preparation within 10 days prior to test article administration or any condition currently requiring regular medication Clinically significant ECG abnormalities or history of cardiac abnormality Past or current history of neurological or neuropsychiatric disease or epilepsy Subjects with orthostatic hypotension at the screening evaluation History of drug or alcohol abuse or regular use of ≥ 3 cigarettes per day Use of alcohol or other drugs of abuse within 72 hours before test article administration Any condition, in the investigator's opinion, that places the subject at undue risk Subjects who have donated blood within 8 weeks before study entry Subjects with ocular onchocerciasis in cohorts intended to enroll subjects with mild infection. Ocular onchocerciasis is defined by the presence of live or dead microfilariae, onchocercal punctate opacities, onchocercal lesions of the posterior segment or lesions that mimic those seen in onchocerciasis. Subjects with hyperreactive onchodermatitis Antifilarial therapy within the previous 5 years Coincidental infection with Loa Loa Female subjects of childbearing potential with a contraindication to DMPA if not on Norplant Any other condition which the investigator feels would exclude the subject from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Opoku, MD
Organizational Affiliation
Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onchocerciasis Chemotherapy Research Center
City
Hohoe
State/Province
Volta Region
Country
Ghana

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24968000
Citation
Awadzi K, Opoku NO, Attah SK, Lazdins-Helds J, Kuesel AC. A randomized, single-ascending-dose, ivermectin-controlled, double-blind study of moxidectin in Onchocerca volvulus infection. PLoS Negl Trop Dis. 2014 Jun 26;8(6):e2953. doi: 10.1371/journal.pntd.0002953. eCollection 2014 Jun.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4072596/pdf/pntd.0002953.pdf
Description
Awadzi et al 2014

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Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

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