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Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

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ClinicalTrials.gov Identifier: NCT00300768
Recruitment Status : Completed
First Posted : March 9, 2006
Last Update Posted : December 15, 2022
World Health Organization
Information provided by (Responsible Party):
Medicines Development for Global Health

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).

Condition or disease Intervention/treatment Phase
Onchocerciasis Drug: 2 mg moxidectin Drug: ivermectin 150 mcg/kg Drug: 4 mg moxidectin Drug: 8 mg moxidectin Phase 2

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 different degrees of severity of O. volvulus infection. The study was conducted at a single site in Ghana.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 6, 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 29, 2009

Arm Intervention/treatment
Experimental: 2 mg moxidectin
2 mg moxidectin (Dose-escalation 1st step)
Drug: 2 mg moxidectin
Single-dose, tablet encapsulated for blinding

Active Comparator: Ivermectin 150 mcg/kg
Active comparator arm (ivermectin 150 mcg/kg).
Drug: ivermectin 150 mcg/kg
Single-dose, tablets encapsulated for blinding

Experimental: 4 mg moxidectin
4 mg moxidectin (dose escalation second step)
Drug: 4 mg moxidectin
Single dose, tablets encapsulated for blinding

Experimental: 8 mg moxidectin
8 mg moxidectin (dose escalation third step)
Drug: 8 mg moxidectin
single dose, tablets encapsulated for blinding

Primary Outcome Measures :
  1. Incidence of clinical adverse events and clinically significant laboratory test results [ Time Frame: Duration of follow up (18 months) ]

Secondary Outcome Measures :
  1. Skin mf counts at day 8 and months 1, 2, 3, 6, 12 and 18 [ Time Frame: day 8 and months 1, 2, 3, 6, 12, 18 ]
  2. Nodulectomy at 18 months [ Time Frame: 18 months ]
  3. Pharmacokinetics (PKs) at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12 [ Time Frame: days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300768

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Onchocerciasis Chemotherapy Research Center
Hohoe, Volta Region, Ghana
Sponsors and Collaborators
Medicines Development for Global Health
World Health Organization
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Principal Investigator: Nicholas Opoku, MD Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana
Additional Information:
Publications of Results:
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Responsible Party: Medicines Development for Global Health
ClinicalTrials.gov Identifier: NCT00300768    
Other Study ID Numbers: 3110A1-200-GH
B1751004 ( Other Identifier: Protocol ID: Pfizer )
OCRC 33 ( Other Identifier: Protocol ID: WHO, OCRC )
First Posted: March 9, 2006    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medicines Development for Global Health:
onchocerca volvulus
river blindness
Additional relevant MeSH terms:
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Intestinal Volvulus
Spirurida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Torsion Abnormality
Pathological Conditions, Anatomical
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents