Evidence map›Paper›PMID 37890967›Full record

ArticleBMJ open2023

Phase II randomised placebo-controlled trial of sodium selenate as a disease-modifying treatment in chronic drug-resistant temporal lobe epilepsy: the SeLECT study protocol.

Lucy Vivash, Hannah Johns, Leonid Churilov, Sara MacPhail, Pablo Casillas-Espinosa, Charles Malpas, Sandy R Shultz, Chris Tailby, Manori Wijayath, David Reutens and 9 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.6field-weighted citation impact, top 17% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. 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

19 authors at 8 institutions in 1 country.

Lucy VivashDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia lucy.vivash@monash.edu.ORCID 0000-0002-1182-0907
Hannah JohnsDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
Leonid ChurilovDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
Sara MacPhailDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.
Pablo Casillas-EspinosaDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.
Charles MalpasDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.
Sandy R ShultzDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.
Chris TailbyFlorey Institute of Neuroscience and Mental Health - Austin Campus, Heidelberg, Victoria, Australia.
Manori WijayathDepartment of Neurology, Westmead Hospital, Westmead, New South Wales, Australia.
David ReutensDepartment of Neurology, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
Lisa GillinderEpilepsy Unit, Mater Hospital Brisbane, Brisbane, Queensland, Australia.
Piero PeruccaDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.
Patrick CarneyBladin-Berkovic Comprehensive Epilepsy Program, Department of Neurology, Austin Health, Heidelberg, texas, Australia.
John-Paul NicoloDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.
Nicholas LawnSir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
Patrick KwanDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.
Dennis VelakoulisDepartment of Neuropsychiatry, Royal Melbourne Hospital, Parkville, Victoria, Australia.
Christopher M HovensDepartment of Surgery, Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia.
Terence J O'BrienDepartment of Neuroscience, Monash University, Melbourne, Victoria, Australia.
The Royal Melbourne Hospital · AUThe University of Melbourne · AUThe University of Queensland · AUEastern Health · AUFlorey Institute of Neuroscience and Mental Health · AUMonash University · AUSir Charles Gairdner Hospital · AUWestmead Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEpilepsy is one of the most common neurological conditions worldwide. Despite many antiseizure medications (ASMs) being available, up to one-third of patients do not achieve seizure control. Preclinical studies have shown treatment with sodium selenate to have a disease-modifying effect in a rat model of chronic temporal lobe epilepsy (TLE).

aimThis randomised placebo-controlled trial aims to evaluate the antiseizure and disease-modifying effects of sodium selenate in people with drug-resistant TLE.

methodsThis will be a randomised placebo-controlled trial of sodium selenate. One hundred and twenty-four adults with drug-resistant TLE and ≥4 countable seizures/month will be recruited. Outcomes of interest will be measured at baseline, week 26 and week 52 and include an 8-week seizure diary, 24-hour electroencephalogram and cognitive, neuropsychiatric and quality of life measures. Participants will then be randomised to receive a sustained release formulation of sodium selenate (initially 10 mg three times a day, increasing to 15 mg three times a day at week 4 if tolerated) or a matching placebo for 26 weeks. OUTCOMES: The primary outcome will be a consumer codesigned epilepsy-Desirability of Outcome Rank (DOOR), combining change in seizure frequency, adverse events, quality of life and ASM burden measures into a single outcome measure, compared between treatment arms over the whole 52-week period. Secondary outcomes will compare baseline measures to week 26 (antiseizure) and week 52 (disease modification). Exploratory measures will include biomarkers of treatment response. ETHICS AND DISSEMINATION: The study has been approved by the lead site, Alfred Hospital Ethics Committee (594/20). Each participant will provide written informed consent prior to any trial procedures. The results of the study will be presented at national and international conferences, published in peer-reviewed journals and disseminated through consumer organisations.

conclusionThis study will be the first disease-modification randomised controlled trial in patients with drug-resistant TLE. TRIAL REGISTRATION NUMBER: ANZCTR; ACTRN12623000446662.

Indexed as

Drug Resistant EpilepsyEpilepsy, Temporal LobeAdultAnimalsClinical Trials, Phase II as TopicHumansQuality of LifeRandomized Controlled Trials as TopicRatsSeizuresSelenic AcidTreatment OutcomeSelenic Acidclinical trialepilepsyrandomized controlled trial

Identifiers

PMID37890967
PMCPMC10619053
OpenAlexW4387978514

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.