Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

NCT00300768 | Completed Phase 2 DMC

• 3 other identifiers: 3110A1-200-GHB1751004OCRC 33
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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).

Conditions

Onchocerciasis

Keywords

onchocerciasis; onchocerca volvulus; river blindness; ivermectin; moxidectin

Outcome Measures

Primary Outcomes (1)

• Incidence of clinical adverse events and clinically significant laboratory test results

  Duration of follow up (18 months)

Secondary Outcomes (3)

• Skin mf counts at day 8 and months 1, 2, 3, 6, 12 and 18

  day 8 and months 1, 2, 3, 6, 12, 18

• Nodulectomy at 18 months

  18 months

• Pharmacokinetics (PKs) at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12

  days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12

Study Arms (4)

2 mg moxidectin

EXPERIMENTAL

2 mg moxidectin (Dose-escalation 1st step)

Drug: 2 mg moxidectin

Ivermectin 150 mcg/kg

ACTIVE COMPARATOR

Active comparator arm (ivermectin 150 mcg/kg).

Drug: ivermectin 150 mcg/kg

4 mg moxidectin

EXPERIMENTAL

4 mg moxidectin (dose escalation second step)

Drug: 4 mg moxidectin

8 mg moxidectin

EXPERIMENTAL

8 mg moxidectin (dose escalation third step)

Drug: 8 mg moxidectin

Interventions

2 mg moxidectin DRUG

Single-dose, tablet encapsulated for blinding

2 mg moxidectin

ivermectin 150 mcg/kg DRUG

Single-dose, tablets encapsulated for blinding

Ivermectin 150 mcg/kg

4 mg moxidectin DRUG

Single dose, tablets encapsulated for blinding

4 mg moxidectin

8 mg moxidectin DRUG

single dose, tablets encapsulated for blinding

8 mg moxidectin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Use of alcohol or other drugs of abuse within 72 hours before test article administration
• Any condition, in the investigator's opinion, that places the subject at undue risk
• Subjects who have donated blood within 8 weeks before study entry
• 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.
• Subjects with hyperreactive onchodermatitis
• Antifilarial therapy within the previous 5 years
• Coincidental infection with Loa Loa

Sponsors & Collaborators

• Medicines Development for Global Health: lead
• World Health Organization: collaborator

Study Sites (1)

Onchocerciasis Chemotherapy Research Center

Hohoe, Volta Region, Ghana

Location

Related Publications (1)

• 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.

  PMID: 24968000 RESULT

Related Links

• Awadzi et al 2014

MeSH Terms

Conditions

Onchocerciasis; Onchocerciasis, Ocular

Interventions

moxidectin; Ivermectin

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Eye Infections, Parasitic; Vector Borne Diseases; Eye Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Nicholas Opoku, MD

  Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 9, 2006
• Study Start: September 6, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 29, 2009
• Last Updated: December 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)