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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 14 January 2019
Main ID:  NCT03052998
Date of registration: 10/02/2017
Prospective Registration: Yes
Primary sponsor: Robert Colebunders
Public title: Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy OAETREAT
Scientific title: Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy: A Randomized Clinical Trial
Date of first enrolment: October 1, 2017
Target sample size: 91
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
Congo, The Democratic Republic of the
Name:     Michel Mandro, MD
Affiliation:  Chef de Bureau Inspection&Contrôle et Associé de Recherche Clinique
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 5 years and above

- Signed informed consent form

- Normal neurological development until onset of epilepsy

- Onset of epilepsy between ages of 5 and 18 years

- Seizure frequency of =2 seizures per month

- Presence of microfilaria in skin snip and/or antibodies against Ov16

Exclusion Criteria:

- Ivermectin intake the last 9 months

- Pregnancy or breastfeeding

- Known or suspected allergy to Ivermectin

- Loa Loa microfilariae in blood

- Epilepsy with known cause (e.g. severe head trauma, perinatal asphyxia, patients with
a history of cerebral malaria, meningitis or encephalitis)

Age minimum: 5 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Drug: Ivermectin
Primary Outcome(s)
seizure freedom [Time Frame: 4 months]
Secondary Outcome(s)
>50 % reduction in seizure frequency [Time Frame: 4 months]
Secondary ID(s)
ERC grant No.671055
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
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