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Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00300768
First Posted: March 9, 2006
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Medicines Development Limited
  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
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

Resource links provided by NLM:


Further study details as provided by Medicines Development Limited:

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

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 ]
  • Nodulectomy at 18 months [ Time Frame: 18 months ]
  • 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 ]

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

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
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
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


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

Additional Information:
Publications:
Responsible Party: Medicines Development Limited
ClinicalTrials.gov Identifier: NCT00300768     History of Changes
Other Study ID Numbers: OCRC-33 - 980819(B)
First Submitted: March 7, 2006
First Posted: March 9, 2006
Last Update Posted: November 17, 2017
Last Verified: February 2012

Keywords provided by Medicines Development Limited:
onchocerciasis
onchocerca volvulus
river blindness
ivermectin
moxidectin

Additional relevant MeSH terms:
Onchocerciasis
Intestinal Volvulus
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Torsion Abnormality
Pathological Conditions, Anatomical
Ivermectin
Milbemycin
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Antinematodal Agents