Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy (OAETREATe)

Universiteit Antwerpen

Status and phase: Completed; Phase 4

Conditions: Epilepsy

Treatments: Drug: ivermectin

Study type: Interventional

Funder types: Other

Identifiers

NCT03852303

B300201733349

Details and patient eligibility

About

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.

Full 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.

Enrollment: 197 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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197 participants in 3 patient groups

ivermectin once a year

Active Comparator group

Description:

Ivermectin one dose per year and anti-epileptic treatment

Treatment:

Drug: ivermectin

ivermectin 2 times a year

Experimental group

Description:

Ivermectin one dose 2 times a year and anti-epileptic treatment

Treatment:

Drug: ivermectin

ivermectin 3 times a year

Experimental group

Description:

vermectin one dose 3 times a year and anti-epileptic treatment

Treatment:

Drug: ivermectin