Clinical trials of drugs for onchocerciasis: a randomised, single-ascending-dose, ivermectin-controlled, double-blind, safety, tolerability, pharmacokinetic, and efficacy study of orally administered moxidectin in subjects with Onchocerca volvulus infection (Ghana)

ISRCTN	ISRCTN45231833
DOI	https://doi.org/10.1186/ISRCTN45231833
ClinicalTrials.gov number	NCT00300768
Secondary identifying numbers	980819 (B)

Submission date: 15/04/2005
Registration date: 07/06/2005
Last edited: 20/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr A C Kuesel
Scientific

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

Email	kuesela@who.int

Study information

Study design	Randomised, single ascending dose, active-control, double-blind trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	Clinical trials of drugs for onchocerciasis: a randomised, single-ascending-dose, ivermectin-controlled, double-blind, safety, tolerability, pharmacokinetic, and efficacy study of orally administered moxidectin in subjects with Onchocerca volvulus infection (Ghana)
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.
Ethics approval(s)	1. Ghana Health Service Ethical Review Committee, 24/08/2006 2. World Health Organization (WHO) Ethics Review Committee, 28/06/2006
Condition	Onchocerciasis
Intervention	Single dose of moxidectin of 2 mg, 4 mg or 8 mg, or ivermectin at the approved dose.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Moxidectin, ivermectin
Primary outcome measure	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 study start date	01/09/2006
Overall study end date	29/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	192
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 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	30/06/2008

Locations

Countries of recruitment

Ghana
Switzerland

Study participating centre

World Health Organization

Geneva -27
CH 1211
Switzerland

Sponsor information

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

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

Website	http://www.who.int
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/06/2014	20/02/2019	Yes	No

Editorial Notes

20/02/2019: Publication reference added.
03/12/2009: This record was updated to include the actual end date of participant follow-up; the previous overall trial end date was 31/12/2009.
11/08/2008: This trial completed recruitment on the 30/06/2008. The end of follow-up is expected for 31/12/2009, and the below overall trial end date has been changed to reflect this. The previous overall trial end date was 01/09/2009.