Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

This study has been completed.
Sponsor:
Information provided by:
World Health Organization
ClinicalTrials.gov Identifier:
NCT00300768
First received: March 7, 2006
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by World Health Organization:

Primary Outcome Measures:
  • Incidence of clinical adverse events and clinically significant laboratory test results [ Time Frame: Duration of follow up (18 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Nodulectomy at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: September 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300768

Locations
Ghana
Onchocerciasis Chemotherapy Research Center
Hohoe, Volta Region, Ghana
Sponsors and Collaborators
World Health Organization
Investigators
Principal Investigator: Nicholas Opoku, MD Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana
  More Information

No publications provided by World Health Organization

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00300768     History of Changes
Other Study ID Numbers: OCRC-33 - 980819(B)
Study First Received: March 7, 2006
Last Updated: February 13, 2012
Health Authority: Ghana : Food and Drugs Board

Keywords provided by World Health Organization:
onchocerciasis
onchocerca volvulus
river blindness
ivermectin
moxidectin

Additional relevant MeSH terms:
Onchocerciasis
Filariasis
Helminthiasis
Nematode Infections
Parasitic Diseases
Secernentea Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Spirurida Infections
Ivermectin
Milbemycin
Anthelmintics
Anti-Infective Agents
Antinematodal Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014