Evidence map›Paper›PMID 30841858›Full record

ArticleBMC neurology2019

Doxycycline for the treatment of nodding syndrome (DONS); the study protocol of a phase II randomised controlled trial.

Richard Idro, Ronald Anguzu, Rodney Ogwang, Pamela Akun, Catherine Abbo, Amos Deogratius Mwaka, Bernard Opar, Phyellister Nakamya, Mark Taylor, Alison Elliott and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02850913 (Doxycycline for the Treatment of Nodding Syndrome), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.7field-weighted citation impact, top 16% 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.

NCT02850913 phase2unknown statusnot on this map

Doxycycline for the Treatment of Nodding Syndrome: A Phase II, Randomised Placebo Controlled Trial

TypeinterventionalSponsorMakerere UniversityRan2016 to 2020Enrolled230ConditionsSeizuresArmsDoxycycline, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Epilepsy inFrontiers in neurology · 2021
    Article
  9. Review
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

13 authors at 8 institutions in 3 countries.

Richard IdroCollege of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda. ridro1@gamil.com.ORCID http://orcid.org/0000-0003-4728-4605
Ronald AnguzuCollege of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.
Rodney OgwangCollege of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.
Pamela AkunCollege of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.
Catherine AbboCollege of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.
Amos Deogratius MwakaCollege of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.
Bernard OparMinistry of Health, P.O Box 7272, Kampala, Uganda.
Phyellister NakamyaMinistry of Health, P.O Box 7272, Kampala, Uganda.
Mark TaylorLiverpool School of Tropical Medicine, Pembroke Place, Liverpool, L35QA, UK.
Alison ElliottMedical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit, P.O Box 49, Entebbe, Uganda.
Angela VincentNuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, OX3 9TH, UK.
Charles NewtonDepartment of Psychiatry, St John's College, University of Oxford, St Giles, Oxford, OX1 3JP, UK.
Kevin MarshCentre for Tropical Medicine and Global Health, University of Oxford, Oxford, OX3 7FZ, UK.
International Institute of Tropical Agriculture · UGMakerere University · UGMinistry of Health · UGUniversity of Oxford · GBAngkor Hospital for Children · KHJohn Radcliffe Hospital · GBLiverpool School of Tropical Medicine · GBUganda Virus Research Institute · UG

Funding

Medical Research Council MC_UU_00027/5Medical Research Council MR/M025489/1
6 · The paper itself

Abstract

backgroundNodding syndrome is a poorly understood neurological disorder of unknown aetiology, affecting several thousand children in Africa. There has been a consistent epidemiological association with infection by the filarial parasite, Onchocerca volvulus and antibodies to leiomodin and DJ-1, cross-reacting with O.volvulus proteins, have been reported. We hypothesized that nodding syndrome is a neuro-inflammatory disorder, induced by antibodies to O.volvulus or its symbiont, Wolbachia, cross-reacting with human neuron proteins and that doxycycline, which kills Onchocerca through effects on Wolbachia, may be used as treatment.

methodsThis will be a two-arm, double-blind, placebo-controlled, randomised phase II trial of doxycycline 100 mg daily for six weeks in 230 participants. Participants will be patients' ages≥8 years with nodding syndrome. They will receive standard of care supportive treatment. All will be hospitalised for 1-2 weeks during which time baseline measurements including clinical assessments, EEG, cognitive and laboratory testing will be performed and antiepileptic drug doses rationalised. Participants will then be randomised to either oral doxycycline (Azudox®, Kampala Pharmaceutical Industries) 100 mg daily or placebo. Treatment will be initiated in hospital and continued at home. Participants will be visited at home at 2, 4 and 6 weeks for adherence monitoring. Study outcomes will be assessed at 6, 12, 18 and 24-month visits. Analysis will be by intention to treat. The primary efficacy outcome measure will be the proportion of patients testing positive and the levels or titires of antibodies to host neuron proteins (HNPs) and/or leiomodin at 24 months. Secondary outcome measures will include effect of the intervention on seizure control, inflammatory markers, cognitive function, disease severity and quality of life. DISCUSSION: This trial postulates that targeting O.volvulus through drugs which kill Wolbachia can modify the pathogenic processes in nodding syndrome and improve outcomes. Findings from this study are expected to substantially improve the understanding and treatment of nodding syndrome.

trial registrationRegistered with clinicaltrials.gov ID: NCT02850913 on 1st August, 2016.

Indexed as

Antiparasitic AgentsDoxycyclineNodding SyndromeAnimalsChildClinical Trials, Phase II as TopicDouble-Blind MethodHumansMaleOnchocerca volvulusQuality of LifeRandomized Controlled Trials as TopicResearch DesignTreatment OutcomeUgandaAntiparasitic AgentsDoxycyclineDoxycyclineNodding syndromeOnchocerca volvulusRandomized controlled trial

Identifiers

PMID30841858
PMCPMC6402111
OpenAlexW2923669877

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.