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Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

Information source: World Health Organization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Onchocerciasis

Intervention: 2 mg moxidectin (Drug); ivermectin 150 mcg/kg (Drug); 4 mg moxidectin (Drug); 8 mg moxidectin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: World Health Organization

Official(s) and/or principal investigator(s):
Nicholas Opoku, MD, Principal Investigator, Affiliation: Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana


The primary purpose of this study is to determine the safety and tolerability of moxidectin in subjects infected with O. volvulus with special emphasis on Mazzotti reactions to determine whether it is safe enough to expose a number of subjects sufficient for obtaining statistically significant data on the safety and efficacy of moxidectin relative to ivermectin. 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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Incidence of clinical adverse events and clinically significant laboratory test results

Secondary outcome:

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


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria: 1. Written, signed (or thumb-printed), and dated informed consent 2. Aged 18 to 60 years, inclusive 3. Body weight ≥ 40 kg for women and ≥ 45 kg for men 4. Nonpregnant, nonbreastfeeding women. Women of child bearing potential must agree to use birth control during the first 150 days after treatment. 5. 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 6. Adequate hematologic, renal, and hepatic function 7. Skin microfilarial density within the required range for the cohort Exclusion Criteria: 1. Participation in any studies other than purely observational ones, within 4 weeks before test article administration. 2. Any vaccination within 4 weeks before test article administration 3. Acute infection requiring therapy within the last 10 days before test article administration 4. 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 5. Clinically significant ECG abnormalities or history of cardiac abnormality 6. Past or current history of neurological or neuropsychiatric disease or epilepsy 7. Subjects with orthostatic hypotension at the screening evaluation 8. History of drug or alcohol abuse or regular use of ≥ 3 cigarettes per day 9. Use of alcohol or other drugs of abuse within 72 hours before test article administration 10. Any condition, in the investigator's opinion, that places the subject at undue risk 11. Subjects who have donated blood within 8 weeks before study entry 12. 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. 13. Subjects with hyperreactive onchodermatitis 14. Antifilarial therapy within the previous 5 years 15. Coincidental infection with Loa Loa 16. Female subjects of childbearing potential with a contraindication to DMPA if not on Norplant 17. Any other condition which the investigator feels would exclude the subject from the study

Locations and Contacts

Onchocerciasis Chemotherapy Research Center, Hohoe, Volta Region, Ghana
Additional Information

Starting date: September 2006
Last updated: February 13, 2012

Page last updated: August 23, 2015

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