Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy (OAETREAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03052998|
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : January 7, 2019
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.
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.
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Ivermectin Onchocerciasis Epilepsy||Drug: Ivermectin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized clinical trial|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy: A Randomized Clinical Trial|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||August 1, 2018|
Active Comparator: Ivermectin
Ivermectin and anti-epileptic treatment
Effect of Ivermectin on frequency of seizures
Other Name: anti-epileptic drugs
No Intervention: no treatment
only anti-epileptic treatment
- seizure freedom [ Time Frame: 4 months ]absence of seizures month 4
- >50 % reduction in seizure frequency [ Time Frame: 4 months ]>50 % reduction in seizure frequency compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052998
|Congo, The Democratic Republic of the|
|Centre de Recherche en Maladies Tropicales de l'Ituri|
|Rethy, Ituri, Congo, The Democratic Republic of the|
|Principal Investigator:||Michel Mandro, MD||Chef de Bureau Inspection&Contrôle et Associé de Recherche Clinique|