Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy

NCT03052998

Ivermectin Onchocerciasis Epilepsy

COMPLETED PHASE4

Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area

NCT05749653

Onchocerciasis Epilepsy

COMPLETED NA

Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis

NCT03876262

Onchocerciasis

ACTIVE_NOT_RECRUITING PHASE3

Safety and Efficacy of IDA for Onchocerciasis

NCT04188301

Onchocerciasis

COMPLETED PHASE2

Prevalence of LF Infection in Districts Not Included in LF Control Activities

NCT03131401

Lymphatic Filariases Onchocerciasis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ivermectin once a year

Ivermectin one dose per year and anti-epileptic treatment

Group Type ACTIVE_COMPARATOR

ivermectin

Intervention Type DRUG

evaluate effect of ivermectin on frequency of seizures

ivermectin 2 times a year

Ivermectin one dose 2 times a year and anti-epileptic treatment

Group Type EXPERIMENTAL

ivermectin

Intervention Type DRUG

evaluate effect of ivermectin on frequency of seizures

ivermectin 3 times a year

vermectin one dose 3 times a year and anti-epileptic treatment

Group Type EXPERIMENTAL

ivermectin

Intervention Type DRUG

evaluate effect of ivermectin on frequency of seizures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ivermectin

evaluate effect of ivermectin on frequency of seizures

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

anti-epileptic treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No