Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy
NCT03852303 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 197
Last updated 2019-09-26
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.
Conditions
Interventions
- DRUG
-
ivermectin
evaluate effect of ivermectin on frequency of seizures
Sponsors & Collaborators
- collaborator OTHER
-
Universiteit Antwerpen
lead OTHER
Principal Investigators
-
Robert Colebunders, MD,PhD · Universiteit Antwerpen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-01
- Primary Completion
- 2019-03-31
- Completion
- 2019-07-01
Countries
- Democratic Republic of the Congo
Study Locations
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