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
Summary
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 18Nodulectomy at 18 months Pharmacokinetics (PKs) at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
|