Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy (OAETREATe)

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: ivermectin

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.

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 4

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Ituri
    • Rethy, Ituri, Congo, The Democratic Republic of the
      • Centre de Recherche en Maladies Tropicales de l'Ituri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ivermectin once a year; Ivermectin one dose per year and anti-epileptic treatment	Drug: ivermectin; evaluate effect of ivermectin on frequency of seizures; Other Names: anti-epileptic treatment
Experimental: ivermectin 2 times a year; Ivermectin one dose 2 times a year and anti-epileptic treatment	Drug: ivermectin; evaluate effect of ivermectin on frequency of seizures; Other Names: anti-epileptic treatment
Experimental: ivermectin 3 times a year; vermectin one dose 3 times a year and anti-epileptic treatment	Drug: ivermectin; evaluate effect of ivermectin on frequency of seizures; Other Names: anti-epileptic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seizure freedom	no seizures	month 9-12

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: European Research Council
• Investigators: Principal Investigator: Robert Colebunders, MD,PhD, Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Infections; Parasitic Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Filariasis; Epilepsy; Onchocerciasis; Anti-Infective Agents; Antiparasitic Agents; Anticonvulsants; Ivermectin
• Other Study ID Numbers: B300201733349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: A
• IPD Sharing Time Frame: After publication of results
• IPD Sharing Access Criteria: Approval of the PI
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No