Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A C Kuesel

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva -27
CH 1211
Switzerland
kuesela@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00300768

Protocol/serial number

980819 (B)

Study information

Scientific title

Acronym

Study hypothesis

Orally administered moxidectin is safe and well tolerated in subjects infected with Onchocerca volvulus and leads to long term suppression of skin microfilaria.

Added 11/08/2008:
This trial completed recruitment on the 30th June 2008. The end of follow-up is expected for 31st December 2009, and the below end date has been changed to reflect this. The previous anticipated end date of this trial was 01/09/2009.

As of 03/12/2009 this record was updated to include the actual end date of participant follow-up; the previous anticipated end date was 31/12/2009.

Ethics approval

Ethics approval received from:
1. Ghana Health Service Ethical Review Committee (last approval date 24 August 2006)
2. World Health Organization (WHO) Ethics Review Committee (last approval date 28 June 2006)

Study design

Randomised, single ascending dose, active-control, double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Onchocerciasis

Intervention

Single dose of moxidectin of 2 mg, 4 mg or 8 mg, or ivermectin at the approved dose.

Intervention type

Drug

Phase

Not Specified

Drug names

Moxidectin, ivermectin

Primary outcome measures

Data on safety and tolerability of a single oral dose of moxidectin (2, 4, or 8 mg).

Secondary outcome measures

Skin microfilaria levels up to 18 months post treatment.

Overall trial start date

01/09/2006

Overall trial end date

29/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ivermectin-naïve men and women otherwise healthy, with O. volvulus infection
2. Informed consent
3. Aged 18 to 60 years
4. Body weight more than or equal to 40 kg for women, or more than or equal to 45 kg for men
5. Non-pregnant, non-lactating, willing to use contraception during the first 150 days after treatment
6. Normal medical history, physical examination, Electrocardiogram (ECG) and lab results
7. Adequate hematologic, renal and hepatic functions
8. Skin microfilarial density within the required range for the cohort

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

192

Participant exclusion criteria

1. Participation in any studies other than purely observational ones within four weeks before test article administration
2. Any vaccination within four weeks before test article administration
3. Acute infection requiring therapy within the last ten days before test article administration
4. Any medication (with the exception of medication required to treat any reactions during the screening fluorescein angiography (chlorpheniramine) or paracetamol) or herbal preparation within ten days prior to test article administration or any condition currently requiring regular medication
5. History of drug or alcohol abuse or regular use of more than three cigarettes/day, use of alcohol or other drugs of abuse within 72 hours before test article administration
6. Blood donation within eight weeks before study entry
7. Clinically significant ECG abnormalities, or history of cardiac abnormalities, or past or current history of neurological or neuropsychiatric disease or epilepsy
8. Ocular onchocerciasis
9. Hyperactive onchodermatitis
10. Antifilaria therapy within previous five years
11. Coincidental infection with Loa Loa
12. Orthostatic hypotension
13. Female patient with contraindication to DepoMedroxyProgesterone Acetate (DMPA) if not on Norplant

Recruitment start date

01/09/2006

Recruitment end date

29/11/2009

Locations

Countries of recruitment

Ghana

Trial participating centre

World Health Organization
Geneva -27
CH 1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes