CompletedPhase 2

Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

Ghana172 participantsStarted 2006-09-06

Plain-language 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).

Who can participate

Age range18 Years – 60 Years

SexALL

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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

What they're measuring

Incidence of clinical adverse events and clinically significant laboratory test results

Timeframe: Duration of follow up (18 months)

Trial details

NCT IDNCT00300768

SponsorMedicines Development for Global Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

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