Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03852303

Acronym

OAETREATe

Enrollment

197

Registered

2019-02-25

Start date

2017-10-01

Completion date

2019-07-01

Last updated

2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

DRUGivermectin

evaluate effect of ivermectin on frequency of seizures

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Intervention model description

randomized clinical trial

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
seizure freedom	month 9-12	no seizures

Countries

Democratic Republic of the Congo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026