Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy

Phase 4

Completed

• Conditions: Epilepsy
• Interventions: Drug: ivermectin

• Registration Number: NCT03852303
• Lead Sponsor: Universiteit Antwerpen

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 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

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 Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-25
• Primary Completion: 2019-03-31
• Study Completion: 2019-07-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ivermectin once a year	ivermectin	Ivermectin one dose per year and anti-epileptic treatment
ivermectin 2 times a year	ivermectin	Ivermectin one dose 2 times a year and anti-epileptic treatment
ivermectin 3 times a year	ivermectin	vermectin one dose 3 times a year and anti-epileptic treatment

Primary Outcome Measures

Name	Time	Method
seizure freedom	month 9-12	no seizures

Trial Locations

Locations (1)

Centre de Recherche en Maladies Tropicales de l'Ituri; 🇨🇩 Rethy, Ituri, Congo, The Democratic Republic of the