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Trial record 5 of 103 for:    IVERMECTIN

Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy (OAETREAT)

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ClinicalTrials.gov Identifier: NCT03052998
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Colebunders, Universiteit Antwerpen

Brief Summary:

Many studies have reported an association between epilepsy, including Nodding Syndrome (NS), and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or insufficiently controlled with mass Ivermectin distribution. There is evidence that increasing the coverage of Ivermectin reduces the incidence of epilepsy and anecdotal evidence suggests a reduction in seizure frequency in onchocerciasis associated epilepsy (OAE) patients who receive Ivermectin. Finding an alternative treatment for epilepsy in these patients will have major consequences.

Objective

To assess whether Ivermectin treatment decreases the frequency of seizures and leads to seizure freedom in OAE patients, including patients with NS. If we are able to demonstrate such an effect this would be an extra argument that Onchocerciasis is causing epilepsy and that therefore we should increase our efforts to eliminate onchocerciasis.

Methods

We will conduct a randomized clinical trial in the Democratic Republic of Congo (DRC) to compare seizure freedom in onchocerciasis infested epilepsy patients who receive immediate Ivermectin treatment with delayed (after four months) Ivermectin treatment. All participants will simultaneously receive anti-epileptic drugs (AEDs) according to local guidelines for epilepsy treatment. The primary endpoint is seizure freedom defined as no seizures during the fourth month of follow-up. Secondary endpoint is significant (>50%) seizure reduction compared to baseline seizure frequency. Reduction of seizures will be compared between Ivermectin and non-Ivermectin arms.

Current status

Start of enrolment is planned from March 2017 and we expect to have enrolled all 110 participants by August 2017. Results are expected early 2018.

Discussion

If Ivermectin treatment, in addition to AEDs, is able to lead to seizure freedom or significantly reduces seizure frequency in OAE patients this will have major consequences for epilepsy treatment in Onchocerciasis endemic regions. Ivermectin is donated for free, and in non Loa-Loa endemic regions has negligible side effects. Reducing the burden of epilepsy will have a major impact on quality of life and socio-economic status of families with affected members in Africa.


Condition or disease Intervention/treatment Phase
Ivermectin Onchocerciasis Epilepsy Drug: Ivermectin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy: A Randomized Clinical Trial
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : August 1, 2018


Arm Intervention/treatment
Active Comparator: Ivermectin
Ivermectin and anti-epileptic treatment
Drug: Ivermectin
Effect of Ivermectin on frequency of seizures
Other Name: anti-epileptic drugs

No Intervention: no treatment
only anti-epileptic treatment



Primary Outcome Measures :
  1. seizure freedom [ Time Frame: 4 months ]
    absence of seizures month 4


Secondary Outcome Measures :
  1. >50 % reduction in seizure frequency [ Time Frame: 4 months ]
    >50 % reduction in seizure frequency compared to baseline



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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
  • Seizure frequency of ≥2 seizures per month
  • 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)

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): NCT03052998


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
Robert Colebunders
Investigators
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Principal Investigator: Michel Mandro, MD Chef de Bureau Inspection&Contrôle et Associé de Recherche Clinique

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Colebunders, Professor infectious diseases, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT03052998     History of Changes
Other Study ID Numbers: B300201730821
ERC grant No.671055 ( Other Grant/Funding Number: European Research Council )
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: will be available at an ERC website
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 10.01.19

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ivermectin
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
Anticonvulsants
Antiparasitic Agents
Anti-Infective Agents