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Completed

NCT Number: NCT03852303

Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre de Recherche en Maladies Tropicales de l'Ituri

Rethy, Ituri, Democratic Republic of the Congo

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivermectin

Drug

evaluate effect of ivermectin on frequency of seizures

Other names: anti-epileptic treatment

Primary outcomes

  1. seizure freedom

    Time frame: month 9-12

    no seizures

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • European Research Council

Registry information

Official study title

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

Acronym: OAETREATe

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2019
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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