Ivermectin as an adjuvant to anti-epileptic treatment in persons with onchocerciasis-associated epilepsy: a randomized proof-of-concept clinical trial

Open dataset  for a proof-of-concept randomized clinical trial with a four month follow-up period was conducted to investigate whether ivermectin had an added value in decreasing the frequency of seizures in onchocerciasis-infected persons with epilepsy (PWE). The 90 PWE with epilepsy were randomly allocated to the treatment arms: phenobarbital + ivermectin (n = 44) or phenobarbital alone (n = 46). Two weeks after randomization, a follow-up visit was scheduled to assess the early treatment outcomes and potential side effects of AED. After the second week visit, PWE had to report to the health center for further follow-up consultations by the project nurses and medical doctors, scheduled at 1, 2, 3 and 4 months. By March 2018, 89 (99%) participants in both arms attended the final follow-up visit. The trial was conducted in five onchocerciasis-endemic villages within the Logo health zone in the Ituri province, DRC: Draju, Kanga, Wala, Ulyeko and Thedeja. 

At baseline, information was collected on seizure semiology, seizure frequency, epilepsy risk factors, relevant medical history, previous AED and ivermectin use. Weight and height measurements were carried out on all participants, followed by a complete physical and neurological examination performed by one of the medical doctors who had been trained in epilepsy, or by the neurologist. Cognitive impairment was assessed by determining whether the participant was well oriented in time and place, whether he/she could remember his/her name, was coherent in speech, and was obedient to orders; abnormal behaviour such as unexplained aggressive attitudes and/or wandering episodes were also noted.