Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy

Study Overview
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Brief Summary
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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 a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months. The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.

Detailed Description
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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 a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months.The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.

Official Title
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OAETREAT Extra Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy: a

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: ivermectin


Participation Criteria
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Eligibility Criteria
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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 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) Concomitant acute illness or chronic medication use Chronic alcohol/substance use

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ivermectin once a year<br>Ivermectin one dose per year and anti-epileptic treatment | Drug: ivermectin<br>* evaluate effect of ivermectin on frequency of seizures<br>* Other names: anti-epileptic treatment;|
| Experimental: ivermectin 2 times a year<br>Ivermectin one dose 2 times a year and anti-epileptic treatment | Drug: ivermectin<br>* evaluate effect of ivermectin on frequency of seizures<br>* Other names: anti-epileptic treatment;|
| Experimental: ivermectin 3 times a year<br>vermectin one dose 3 times a year and anti-epileptic treatment | Drug: ivermectin<br>* evaluate effect of ivermectin on frequency of seizures<br>* Other names: anti-epileptic treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seizure freedom | no seizures | month 9-12 |