Back to resultsIvermectin Treatment of Persons With Onchocerciasis-associated Epilepsy (OAETREATe)
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
ivermectin
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
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
Sites / Locations
- Centre de Recherche en Maladies Tropicales de l'Ituri
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
ivermectin once a year
ivermectin 2 times a year
ivermectin 3 times a year
Arm Description
Ivermectin one dose per year and anti-epileptic treatment
Ivermectin one dose 2 times a year and anti-epileptic treatment
vermectin one dose 3 times a year and anti-epileptic treatment
Outcomes
Primary Outcome Measures
seizure freedom
no seizures
Secondary Outcome Measures
Full Information
NCT ID
NCT03852303
First Posted
February 21, 2019
Last Updated
September 24, 2019
Sponsor
Universiteit Antwerpen
Collaborators
European Research Council
1. Study Identification
Unique Protocol Identification Number
NCT03852303
Brief Title
Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy
Acronym
OAETREATe
Official Title
OAETREAT Extra Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy: a
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
European Research Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ivermectin once a year
Arm Type
Active Comparator
Arm Description
Ivermectin one dose per year and anti-epileptic treatment
Arm Title
ivermectin 2 times a year
Arm Type
Experimental
Arm Description
Ivermectin one dose 2 times a year and anti-epileptic treatment
Arm Title
ivermectin 3 times a year
Arm Type
Experimental
Arm Description
vermectin one dose 3 times a year and anti-epileptic treatment
Intervention Type
Drug
Intervention Name(s)
ivermectin
Other Intervention Name(s)
anti-epileptic treatment
Intervention Description
evaluate effect of ivermectin on frequency of seizures
Primary Outcome Measure Information:
Title
seizure freedom
Description
no seizures
Time Frame
month 9-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Colebunders, MD,PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche en Maladies Tropicales de l'Ituri
City
Rethy
State/Province
Ituri
Country
Congo, The Democratic Republic of the
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A
IPD Sharing Time Frame
After publication of results
IPD Sharing Access Criteria
Approval of the PI
Learn more about this trial
Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy
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