Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universiteit Antwerpen
• Collaborator: European Research Council
• Treatments: Anticonvulsants; Ivermectin

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

• 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