Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
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.