Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy

Universiteit Antwerpen197 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

197

Conditions

Epilepsy

Interventions

ivermectinDRUG

evaluate effect of ivermectin on frequency of seizures

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre de Recherche en Maladies Tropicales de l'Ituri

Rethy, Ituri, Democratic Republic of the Congo

Outcomes

Primary Outcomes

seizure freedom

no seizures

Time frame: month 9-12

Data from ClinicalTrials.gov

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