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Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy

NCT03052998 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2019-01-07

No results posted yet for this study

Summary

Many studies have reported an association between epilepsy, including Nodding Syndrome (NS), and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or insufficiently controlled with mass Ivermectin distribution. There is evidence that increasing the coverage of Ivermectin reduces the incidence of epilepsy and anecdotal evidence suggests a reduction in seizure frequency in onchocerciasis associated epilepsy (OAE) patients who receive Ivermectin. Finding an alternative treatment for epilepsy in these patients will have major consequences.

Objective

To assess whether Ivermectin treatment decreases the frequency of seizures and leads to seizure freedom in OAE patients, including patients with NS. If we are able to demonstrate such an effect this would be an extra argument that Onchocerciasis is causing epilepsy and that therefore we should increase our efforts to eliminate onchocerciasis.

Methods

We will conduct a randomized clinical trial in the Democratic Republic of Congo (DRC) to compare seizure freedom in onchocerciasis infested epilepsy patients who receive immediate Ivermectin treatment with delayed (after four months) Ivermectin treatment. All participants will simultaneously receive anti-epileptic drugs (AEDs) according to local guidelines for epilepsy treatment. The primary endpoint is seizure freedom defined as no seizures during the fourth month of follow-up. Secondary endpoint is significant (\>50%) seizure reduction compared to baseline seizure frequency. Reduction of seizures will be compared between Ivermectin and non-Ivermectin arms.

Current status

Start of enrolment is planned from March 2017 and we expect to have enrolled all 110 participants by August 2017. Results are expected early 2018.

Discussion

If Ivermectin treatment, in addition to AEDs, is able to lead to seizure freedom or significantly reduces seizure frequency in OAE patients this will have major consequences for epilepsy treatment in Onchocerciasis endemic regions. Ivermectin is donated for free, and in non Loa-Loa endemic regions has negligible side effects. Reducing the burden of epilepsy will have a major impact on quality of life and socio-economic status of families with affected members in Africa.

Conditions

Interventions

DRUG

Ivermectin

Effect of Ivermectin on frequency of seizures

Sponsors & Collaborators

  • Robert Colebunders

    lead OTHER

Principal Investigators

  • Michel Mandro, MD · Chef de Bureau Inspection&Contrôle et Associé de Recherche Clinique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2017-12-31
Completion
2018-08-01

Countries

  • Democratic Republic of the Congo

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03052998 on ClinicalTrials.gov