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Ivermectin as an adjuvant to anti-epileptic treatment in persons with onchocerciasis-associated epilepsy: A randomized proof-of-concept clinical trial.
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- Author(s): Mandro M;Mandro M; Siewe Fodjo JN; Siewe Fodjo JN; Mukendi D; Mukendi D; Dusabimana A; Dusabimana A; Menon S; Menon S; Haesendonckx S; Haesendonckx S; Lokonda R; Lokonda R; Nakato S; Nakato S; Nyisi F; Nyisi F; Abhafule G; Abhafule G; Wonya'Rossi D; Wonya'Rossi D; Jakwong JM; Jakwong JM; Suykerbuyk P; Suykerbuyk P; Meganck J; Meganck J; Hotterbeekx A; Hotterbeekx A; Colebunders R; Colebunders R
- Source:
PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2020 Jan 10; Vol. 14 (1), pp. e0007966. Date of Electronic Publication: 2020 Jan 10 (Print Publication: 2020).- Publication Type:
Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't- Language:
English - Source:
- Additional Information
- Source: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101291488 Publication Model: eCollection Cited Medium: Internet ISSN: 1935-2735 (Electronic) Linking ISSN: 19352727 NLM ISO Abbreviation: PLoS Negl Trop Dis Subsets: MEDLINE
- Publication Information: Original Publication: San Francisco, CA : Public Library of Science
- Subject Terms: Anticonvulsants/*therapeutic use ; Epilepsy/*drug therapy ; Epilepsy/*etiology ; Ivermectin/*therapeutic use ; Onchocerciasis/*complications ; Onchocerciasis/*drug therapy; Adolescent ; Adult ; Antiparasitic Agents/administration & dosage ; Antiparasitic Agents/therapeutic use ; Democratic Republic of the Congo/epidemiology ; Drug Therapy, Combination ; Epilepsy/epidemiology ; Female ; Humans ; Ivermectin/administration & dosage ; Male ; Onchocerciasis/epidemiology ; Young Adult
- Abstract: Introduction: Recent 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.
Methods: A 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).
Results: Ninety 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.
Conclusion: Whether 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 Registration: Registration: www.clinicaltrials.gov; NCT03052998.
Competing Interests: The authors have declared that no competing interests exist. - References: J Biomed Inform. 2009 Apr;42(2):377-81. (PMID: 18929686)
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Lancet. 1992 Sep 26;340(8822):789-90. (PMID: 1356196) - Molecular Sequence: ClinicalTrials.gov NCT03052998
- Accession Number: 0 (Anticonvulsants)
0 (Antiparasitic Agents)
70288-86-7 (Ivermectin) - Publication Date: Date Created: 20200111 Date Completed: 20200403 Latest Revision: 20200403
- Publication Date: 20240105
- Accession Number: PMC6977765
- Accession Number: 10.1371/journal.pntd.0007966
- Accession Number: 31923177
- Source:
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