Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-01-02 @ 1:39 AM
Study NCT ID:
NCT03852303
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy
Sponsor:
Universiteit Antwerpen
Organization:
Study Overview
Official Title:
OAETREAT Extra Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy: a
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OAETREATe
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: