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CompletedNCT00300768Updated Dec 15, 2022

Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

A Phase 2 interventional study of 2 mg moxidectin and ivermectin 150 mcg/kg in Onchocerciasis, sponsored by Medicines Development for Global Health. Completed at 1 site in Ghana. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-12-15.

Sponsored by Medicines Development for Global Health · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
172
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Onchocerciasis

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Keywords

  • onchocerciasis
  • onchocerca volvulus
  • river blindness
  • ivermectin
  • moxidectin
03

In context

Onchocerciasis

34 studies on the registry are indexed under Onchocerciasis; 6 are open to participants now.

This study's enrollment of 172 is below the median of 264 across 24 interventional studies indexed under Onchocerciasis.

Browse Onchocerciasis studies →

Lead sponsor

Medicines Development for Global Health is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
172 participants (actual)

Study arms

  • Experimental
    2 mg moxidectin

    2 mg moxidectin (Dose-escalation 1st step)

    Drug: 2 mg moxidectin

  • Active comparator
    Ivermectin 150 mcg/kg

    Active comparator arm (ivermectin 150 mcg/kg).

    Drug: ivermectin 150 mcg/kg

  • Experimental
    4 mg moxidectin

    4 mg moxidectin (dose escalation second step)

    Drug: 4 mg moxidectin

  • Experimental
    8 mg moxidectin

    8 mg moxidectin (dose escalation third step)

    Drug: 8 mg moxidectin

Interventions

  • Drug2 mg moxidectin

    Single-dose, tablet encapsulated for blinding

  • Drugivermectin 150 mcg/kg

    Single-dose, tablets encapsulated for blinding

  • Drug4 mg moxidectin

    Single dose, tablets encapsulated for blinding

  • Drug8 mg moxidectin

    single dose, tablets encapsulated for blinding

06

What researchers measure

Primary outcomes

  1. Incidence of clinical adverse events and clinically significant laboratory test results

    Time frame: Duration of follow up (18 months)

Secondary outcomes

  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

07

Study locations

1 site
  • Onchocerciasis Chemotherapy Research Center
    Hohoe, Volta Region, Ghana
08

References and documents

Publications

  • 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. PubMed 24968000 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00300768
Lead sponsor
Medicines Development for Global Health
Collaborators
World Health Organization
Responsible party
Sponsor
First posted
Mar 9, 2006
Start date
Sep 6, 2006
Primary completion
Nov 2009
Completion
Nov 29, 2009
Last update
Dec 15, 2022

Study contacts

Nicholas Opoku, MD
principal investigator · Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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