Evidence map›Paper›PMID 31923177›Full record

Trial reportPLoS neglected tropical diseases2020

Ivermectin as an adjuvant to anti-epileptic treatment in persons with onchocerciasis-associated epilepsy: A randomized proof-of-concept clinical trial.

Michel Mandro, Joseph Nelson Siewe Fodjo, Deby Mukendi, Alfred Dusabimana, Sonia Menon, Steven Haesendonckx, Richard Lokonda, Swabra Nakato, Francoise Nyisi, Germain Abhafule and 6 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03052998 (Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
0.4field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03052998 phase4completednot on this map

Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy: A Randomized Clinical Trial

TypeinterventionalSponsorRobert ColebundersRan2017 to 2018Enrolled91ConditionsIvermectin, Onchocerciasis, EpilepsyArmsIvermectin
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 27 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 5 institutions in 2 countries.

Michel MandroProvincial Ministry of Health, Bunia, Ituri, Democratic Republic of Congo.
Joseph Nelson Siewe FodjoGlobal Health Institute, University of Antwerp, Antwerp, Belgium.ORCID 0000-0003-3544-1239
Deby MukendiCentre Neuro-Psycho Pathologique, University of Kinshasa, Kinshasa, Democratic Republic of Congo.
Alfred DusabimanaGlobal Health Institute, University of Antwerp, Antwerp, Belgium.
Sonia MenonGlobal Health Institute, University of Antwerp, Antwerp, Belgium.
Steven HaesendonckxCenter for Statistics, University of Hasselt, Hasselt, Belgium.
Richard LokondaCentre Neuro-Psycho Pathologique, University of Kinshasa, Kinshasa, Democratic Republic of Congo.
Swabra NakatoGlobal Health Institute, University of Antwerp, Antwerp, Belgium.
Francoise NyisiCentre de Recherche en Maladies Tropicales de l'Ituri, Rethy, Ituri, Democratic Republic of Congo.
Germain AbhafuleCentre de Recherche en Maladies Tropicales de l'Ituri, Rethy, Ituri, Democratic Republic of Congo.
Deogratias Wonya'RossiProgramme National de Lutte contre l'Onchocercose, Bunia, Ituri, Democratic Republic of Congo.
Jean Marie JakwongHôpital Général de Référence de Logo, Logo, Ituri, Democratic Republic of Congo.
Patrick SuykerbuykGlobal Health Institute, University of Antwerp, Antwerp, Belgium.
Jacques MeganckGlobal Health Institute, University of Antwerp, Antwerp, Belgium.
An HotterbeekxGlobal Health Institute, University of Antwerp, Antwerp, Belgium.
Robert ColebundersGlobal Health Institute, University of Antwerp, Antwerp, Belgium.ORCID 0000-0002-1919-1340
University of Antwerp · BEUniversity of Kinshasa · CDHasselt University · BEMinistry of Public Health · CDProgramme National Multisectoriel de Lutte contre le sida · CD

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRecent findings from onchocerciasis-endemic foci uphold that increasing ivermectin coverage reduces the epilepsy incidence, and anecdotal evidence suggests seizure frequency reduction in persons with onchocerciasis-associated epilepsy, when treated with ivermectin. We conducted a randomized clinical trial to assess whether ivermectin treatment decreases seizure frequency.

methodsA proof-of-concept randomized clinical trial was conducted in the Logo health zone in the Ituri province, Democratic Republic of Congo, to compare seizure frequencies in onchocerciasis-infected persons with epilepsy (PWE) randomized to one of two treatment arms: the anti-epileptic drug phenobarbital supplemented with ivermectin, versus phenobarbital alone. The primary endpoint was defined as the probability of being seizure-free at month 4. A secondary endpoint was defined as >50% reduction in seizure frequency at month 4, compared to baseline. Both endpoints were analyzed using multiple logistic regression. In longitudinal analysis, the probability of seizure freedom during the follow-up period was assessed for both treatment arms by fitting a logistic regression model using generalized estimating equations (GEE).

resultsNinety PWE enrolled between October and November 2017 were eligible for analysis. A multiple logistic regression analysis showed a borderline association between ivermectin treatment and being seizure-free at month 4 (OR: 1.652, 95% CI 0.975-2.799; p = 0.062). There was no significant difference in the probability of experiencing >50% reduction of the seizure frequency at month 4 between the two treatment arms. Also, treatment with ivermectin did not significantly increase the odds of being seizure-free during the individual follow-up visits.

conclusionWhether ivermectin has an added value in reducing the frequency of seizures in PWE treated with AED remains to be determined. A larger study in persons with OAE on a stable AED regimen and in persons with recent epilepsy onset should be considered to further investigate the potential beneficial effect of ivermectin treatment in persons with OAE.

trial registrationRegistration: www.clinicaltrials.gov; NCT03052998.

Indexed as

AdolescentAdultAnticonvulsantsAntiparasitic AgentsDemocratic Republic of the CongoDrug Therapy, CombinationEpilepsyFemaleHumansIvermectinMaleOnchocerciasisYoung AdultAnticonvulsantsAntiparasitic AgentsIvermectin

Identifiers

PMID31923177
PMCPMC6977765
OpenAlexW2999486915

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.