Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection
NCT ID: NCT00300768
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2006-09-06
2009-11-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2 mg moxidectin
2 mg moxidectin (Dose-escalation 1st step)
2 mg moxidectin
Single-dose, tablet encapsulated for blinding
Ivermectin 150 mcg/kg
Active comparator arm (ivermectin 150 mcg/kg).
ivermectin 150 mcg/kg
Single-dose, tablets encapsulated for blinding
4 mg moxidectin
4 mg moxidectin (dose escalation second step)
4 mg moxidectin
Single dose, tablets encapsulated for blinding
8 mg moxidectin
8 mg moxidectin (dose escalation third step)
8 mg moxidectin
single dose, tablets encapsulated for blinding
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
2 mg moxidectin
Single-dose, tablet encapsulated for blinding
ivermectin 150 mcg/kg
Single-dose, tablets encapsulated for blinding
4 mg moxidectin
Single dose, tablets encapsulated for blinding
8 mg moxidectin
single dose, tablets encapsulated for blinding
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
World Health Organization
OTHER
Medicines Development for Global Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicholas Opoku, MD
Role: PRINCIPAL_INVESTIGATOR
Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Onchocerciasis Chemotherapy Research Center
Hohoe, Volta Region, Ghana
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B1751004
Identifier Type: OTHER
Identifier Source: secondary_id
OCRC 33
Identifier Type: OTHER
Identifier Source: secondary_id
3110A1-200-GH
Identifier Type: -
Identifier Source: org_study_id