Status:
COMPLETED
Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection
Lead Sponsor:
Medicines Development for Global Health
Collaborating Sponsors:
World Health Organization
Conditions:
Onchocerciasis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 differ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 6 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2009
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00300768
Start Date
September 6 2006
End Date
November 29 2009
Last Update
December 15 2022
Active Locations (1)
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1
Onchocerciasis Chemotherapy Research Center
Hohoe, Volta Region, Ghana