Evidence map›Paper›PMID 24702822›Full record

GuidelineEpilepsy research2014

Inclusion and exclusion criteria for epilepsy clinical trials-recommendations from the April 30, 2011 NINDS workshop.

Evan Fertig, Brandy E Fureman, Gregory K Bergey, Mary Ann Brodie, Dale C Hesdorffer, Deborah Hirtz, Eric H Kossoff, W Curt LaFrance, Mark Versavel, Jacqueline French and 1 more

Registry-linked trialAbstract readConsensus Development Conference, NIHGuideline
In one paragraph

Guideline in Epilepsy research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03475225 (Effect of the Treatment of Vitamin D Deficiency in Drug-resistant Epilepsy), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03475225 phase3completednot on this mapstarted 2018, after this paper: background citation

Effect of the Treatment of Vitamin D Deficiency in Drug-resistant Epilepsy

TypeinterventionalSponsorCentre Hospitalier St AnneRan2018 to 2020Enrolled88ConditionsDrug Resistant EpilepsyArmsCholecalciferol, Placebo Oral
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
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

11 authors.

Evan FertigNortheast Regional Epilepsy Group, Hackensack, NJ, United States.
Brandy E FuremanNational Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, United States. Electronic address: furemanb@ninds.nih.gov.
Gregory K BergeyDepartment of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.
Mary Ann BrodieThe Epilepsy Study Consortium, New York City, NY, United States.
Dale C HesdorfferDepartment of Epidemiology, Columbia University, New York, NY, United States.
Deborah HirtzNational Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, United States.
Eric H KossoffDepartment of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States; Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, United States.
W Curt LaFranceDepartments of Psychiatry and Neurology (Research), Brown Medical School, Rhode Island Hospital, Providence, RI, United States.
Mark VersavelSunovion Pharmaceuticals Inc., Marlborough, MA, United States.
Jacqueline FrenchThe Epilepsy Study Consortium, New York City, NY, United States; Department of Neurology, New York University, New York City, NY, United States.
National Institute of Neurological Disorders and Stroke

Funding

Intramural NIH HHS Z99 NS999999
6 · The paper itself

Abstract

On April 30th, 2011 the National Institute of Neurological Disorders and Stroke (NINDS) held a workshop to identify key problems in recent epilepsy clinical trials and propose approaches to address the barriers that impede development of new therapeutic options for epilepsy. Preliminary recommendations were made for selection criteria for subjects entered into epilepsy trials that maximize the scientific impact of the trial and increase the ability to recruit appropriate subjects efficiently and safely. These recommendations were further refined by the authors following the workshop, and subsequently shared with all NINDS workshop participants and with the participants of the 2011 AED XI workshop on epilepsy trials (approximately 200 participants) for further comment. The working group agreed to a final set of criteria that include updated considerations of subject age, clinical semiology, EEG and imaging results, use of prior and current therapies, co-occurring conditions, and suicidality, among others.

Indexed as

Patient SelectionAnticonvulsantsClinical Trials as TopicDrug ResistanceElectroencephalographyEpilepsyHumansNational Institute of Neurological Disorders and Stroke (U.S.)SeizuresUnited StatesAnticonvulsantsClinical trial methodologyComorbidityParticipant selection criteriaRecruitment

Identifiers

PMID24702822
PMCPMC4028380

What OpenQuestion holds

Textmetadata
LicenceTDM
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.