Status:
COMPLETED
Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy
Lead Sponsor:
Universiteit Antwerpen
Collaborating Sponsors:
European Research Council
Conditions:
Epilepsy
Eligibility:
All Genders
5+ years
Phase:
PHASE4
Brief Summary
Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once...
Detailed Description
Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once...
Eligibility Criteria
Inclusion
- 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
- Presence of microfilaria in skin snip and/or antibodies against Ov16
Exclusion
- 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)
- Concomitant acute illness or chronic medication use
- Chronic alcohol/substance use
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT03852303
Start Date
October 1 2017
End Date
July 1 2019
Last Update
September 26 2019
Active Locations (1)
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1
Centre de Recherche en Maladies Tropicales de l'Ituri
Rethy, Ituri, Democratic Republic of the Congo