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Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy (OAETREATe)

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ClinicalTrials.gov Identifier: NCT03852303
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
European Research Council
Information provided by (Responsible Party):
Robert Colebunders, Universiteit Antwerpen

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: ivermectin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: OAETREAT Extra Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy: a
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : July 1, 2019


Arm Intervention/treatment
Active Comparator: ivermectin once a year
Ivermectin one dose per year and anti-epileptic treatment
Drug: ivermectin
evaluate effect of ivermectin on frequency of seizures
Other Name: anti-epileptic treatment

Experimental: ivermectin 2 times a year
Ivermectin one dose 2 times a year and anti-epileptic treatment
Drug: ivermectin
evaluate effect of ivermectin on frequency of seizures
Other Name: anti-epileptic treatment

Experimental: ivermectin 3 times a year
vermectin one dose 3 times a year and anti-epileptic treatment
Drug: ivermectin
evaluate effect of ivermectin on frequency of seizures
Other Name: anti-epileptic treatment




Primary Outcome Measures :
  1. seizure freedom [ Time Frame: month 9-12 ]
    no seizures



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852303


Locations
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Congo, The Democratic Republic of the
Centre de Recherche en Maladies Tropicales de l'Ituri
Rethy, Ituri, Congo, The Democratic Republic of the
Sponsors and Collaborators
Universiteit Antwerpen
European Research Council
Investigators
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Principal Investigator: Robert Colebunders, MD,PhD Universiteit Antwerpen

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Responsible Party: Robert Colebunders, Prof, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT03852303     History of Changes
Other Study ID Numbers: B300201733349
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After publication of results
Access Criteria: Approval of the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Onchocerciasis
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Ivermectin
Anticonvulsants
Antiparasitic Agents
Anti-Infective Agents