Challenges recruiting to a proof-of-concept pharmaceutical trial for a rare disease: the trigeminal neuralgia experience View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-12

AUTHORS

Joanna M. Zakrzewska, Joanne Palmer, Lars Bendtsen, Giulia Di Stefano, Dominik A. Ettlin, Stine Maarbjerg, Mark Obermann, Valerie Morisset, Deb Steiner, Simon Tate, Giorgio Cruccu

ABSTRACT

BACKGROUND: This study aimed to describe recruitment challenges encountered during a phase IIa study of vixotrigine, a state and use-dependent Nav1.7 channel blocker, in individuals with trigeminal neuralgia. METHODS: This was an international, multicenter, placebo-controlled, randomized withdrawal study that included a 7-day run-in period, a 21-day open-label phase, and a 28-day double-blind phase in which patients (planned n = 30) were randomized to vixotrigine or placebo. Before recruitment, all antiepileptic drugs had to be stopped, except for gabapentin or pregabalin. After the trial, patients returned to their original medications. Patient recruitment was expanded beyond the original five planned (core) centers in order to meet target enrollment (total recruiting sites N = 25). Core sites contributed data related to patient identification for study participation (prescreening data). Data related to screening failures and study withdrawal were also analyzed using descriptive statistics. RESULTS: Approximately half (322/636; 50.6%) of the patients who were prescreened at core sites were considered eligible for the study and 56/322 (17.4%) were screened. Of those considered eligible, 26/322 (8.1%) enrolled in the study and 6/322 (1.9%) completed the study. In total, 125 patients were screened across all study sites and 67/125 (53.6%) were enrolled. At prescreening, reasons for noneligibility varied by site and were most commonly diagnosis change (78/314; 24.8%), age > 80 years (75/314; 23.9%), language/distance/mobility (61/314; 19.4%), and noncardiac medical problems (53/314; 16.9%). At screening, frequently cited reasons for noneligibility included failure based on electrocardiogram, insufficient pain, and diagnosis change. CONCLUSIONS: Factors contributing to recruitment challenges encountered in this study included diagnosis changes, anxiety over treatment changes, and issues relating to distance, language, and mobility. Wherever possible, future studies should be designed to address these challenges. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01540630 . EudraCT, 2010-023963-16. 07 Aug 2015. More... »

PAGES

704

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13063-018-3045-1

DOI

http://dx.doi.org/10.1186/s13063-018-3045-1

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1110911708

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30587219


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Clinical Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "University College London Hospitals NHS Foundation Trust", 
          "id": "https://www.grid.ac/institutes/grid.52996.31", 
          "name": [
            "Facial Pain Unit, Division of Diagnostic, Surgical and Medical Sciences, Eastman Dental Hospital, University College London Hospitals NHS Foundation Trust/University College London, London, UK", 
            "Eastman Dental Hospital, 256 Gray\u2019s Inn Road, London, UK", 
            "Pain Management Centre, University College London Hospitals NHS Foundation Trust, London, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Zakrzewska", 
        "givenName": "Joanna M.", 
        "id": "sg:person.0605112763.04", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0605112763.04"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Biogen (United Kingdom)", 
          "id": "https://www.grid.ac/institutes/grid.476070.2", 
          "name": [
            "Convergence Pharmaceuticals Ltd, Cambridge, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Palmer", 
        "givenName": "Joanne", 
        "id": "sg:person.014614064510.09", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014614064510.09"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "Danish Headache Center, Department of Neurology, Rigshospitalet\u2014Glostrup, University of Copenhagen, Valdemar Hansens Vej 5, 2600, Glostrup, Denmark"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Bendtsen", 
        "givenName": "Lars", 
        "id": "sg:person.01121201055.34", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01121201055.34"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Sapienza University of Rome", 
          "id": "https://www.grid.ac/institutes/grid.7841.a", 
          "name": [
            "Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Di Stefano", 
        "givenName": "Giulia", 
        "id": "sg:person.0646714245.50", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0646714245.50"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of Zurich", 
          "id": "https://www.grid.ac/institutes/grid.7400.3", 
          "name": [
            "Interdisciplinary Orofacial Pain Unit, Clinic of Masticatory Disorders, Center of Dental Medicine, University of Zurich, Zurich, Switzerland"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Ettlin", 
        "givenName": "Dominik A.", 
        "id": "sg:person.0622157744.24", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0622157744.24"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "Danish Headache Center, Department of Neurology, Rigshospitalet\u2014Glostrup, University of Copenhagen, Valdemar Hansens Vej 5, 2600, Glostrup, Denmark"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Maarbjerg", 
        "givenName": "Stine", 
        "id": "sg:person.01331543222.87", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01331543222.87"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of Duisburg-Essen", 
          "id": "https://www.grid.ac/institutes/grid.5718.b", 
          "name": [
            "Department of Neurology and German Headache Center, University of Duisburg-Essen, Essen, Germany", 
            "Center for Neurology, Asklepios Hospitals Schildautal, Seesen, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Obermann", 
        "givenName": "Mark", 
        "id": "sg:person.01370442636.75", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01370442636.75"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Biogen (United Kingdom)", 
          "id": "https://www.grid.ac/institutes/grid.476070.2", 
          "name": [
            "Convergence Pharmaceuticals Ltd, Cambridge, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Morisset", 
        "givenName": "Valerie", 
        "id": "sg:person.01253227442.40", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01253227442.40"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Biogen (United States)", 
          "id": "https://www.grid.ac/institutes/grid.417832.b", 
          "name": [
            "Biogen, Cambridge, MA, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Steiner", 
        "givenName": "Deb", 
        "id": "sg:person.014424656727.95", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014424656727.95"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Biogen (United Kingdom)", 
          "id": "https://www.grid.ac/institutes/grid.476070.2", 
          "name": [
            "Convergence Pharmaceuticals Ltd, Cambridge, UK"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Tate", 
        "givenName": "Simon", 
        "id": "sg:person.01303131547.72", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01303131547.72"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Sapienza University of Rome", 
          "id": "https://www.grid.ac/institutes/grid.7841.a", 
          "name": [
            "Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Cruccu", 
        "givenName": "Giorgio", 
        "id": "sg:person.01367274016.99", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01367274016.99"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "https://doi.org/10.1016/j.pain.2006.01.030", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1001039087"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.pain.2006.01.030", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1001039087"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1177/0333102413485658", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1004906592"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1177/0333102413485658", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1004906592"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s13063-016-1322-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1008710204", 
          "https://doi.org/10.1186/s13063-016-1322-4"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/ana.410270114", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1014810421"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0895-4356(99)00141-9", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1015621495"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1745-6215-14-402", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1016693421", 
          "https://doi.org/10.1186/1745-6215-14-402"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s40271-014-0096-6", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1019482041", 
          "https://doi.org/10.1007/s40271-014-0096-6"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1136/bmj.g6802", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1020691613"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.pain.2008.03.002", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1035369935"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.pain.2008.03.002", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1035369935"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/head.12441", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1036505399"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jclinepi.2010.02.007", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1039795884"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1745-6215-7-9", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1045524118", 
          "https://doi.org/10.1186/1745-6215-7-9"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.pain.2009.08.023", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1051817142"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.pain.2009.08.023", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1051817142"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s12603-010-0009-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052693121", 
          "https://doi.org/10.1007/s12603-010-0009-x"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s12603-010-0009-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052693121", 
          "https://doi.org/10.1007/s12603-010-0009-x"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1177/0883073813495959", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1053961422"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1177/0883073813495959", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1053961422"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/j.pain.0000000000000853", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1074213391"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/j.pain.0000000000000853", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1074213391"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1076799822", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1082642225", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s1474-4422(17)30005-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1083849296"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2018-12", 
    "datePublishedReg": "2018-12-01", 
    "description": "BACKGROUND: This study aimed to describe recruitment challenges encountered during a phase IIa study of vixotrigine, a state and use-dependent Nav1.7 channel blocker, in individuals with trigeminal neuralgia.\nMETHODS: This was an international, multicenter, placebo-controlled, randomized withdrawal study that included a 7-day run-in period, a 21-day open-label phase, and a 28-day double-blind phase in which patients (planned n\u00a0=\u200930) were randomized to vixotrigine or placebo. Before recruitment, all antiepileptic drugs had to be stopped, except for gabapentin or pregabalin. After the trial, patients returned to their original medications. Patient recruitment was expanded beyond the original five planned (core) centers in order to meet target enrollment (total recruiting sites N\u00a0=\u200925). Core sites contributed data related to patient identification for study participation (prescreening data). Data related to screening failures and study withdrawal were also analyzed using descriptive statistics.\nRESULTS: Approximately half (322/636; 50.6%) of the patients who were prescreened at core sites were considered eligible for the study and 56/322 (17.4%) were screened. Of those considered eligible, 26/322 (8.1%) enrolled in the study and 6/322 (1.9%) completed the study. In total, 125 patients were screened across all study sites and 67/125 (53.6%) were enrolled. At prescreening, reasons for noneligibility varied by site and were most commonly diagnosis change (78/314; 24.8%), age\u2009>\u200980\u2009years (75/314; 23.9%), language/distance/mobility (61/314; 19.4%), and noncardiac medical problems (53/314; 16.9%). At screening, frequently cited reasons for noneligibility included failure based on electrocardiogram, insufficient pain, and diagnosis change.\nCONCLUSIONS: Factors contributing to recruitment challenges encountered in this study included diagnosis changes, anxiety over treatment changes, and issues relating to distance, language, and mobility. Wherever possible, future studies should be designed to address these challenges.\nTRIAL REGISTRATION: ClinicalTrials.gov, NCT01540630 . EudraCT, 2010-023963-16. 07 Aug 2015.", 
    "genre": "research_article", 
    "id": "sg:pub.10.1186/s13063-018-3045-1", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": true, 
    "isPartOf": [
      {
        "id": "sg:journal.1297400", 
        "issn": [
          "1468-6708", 
          "1745-6215"
        ], 
        "name": "Trials", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "19"
      }
    ], 
    "name": "Challenges recruiting to a proof-of-concept pharmaceutical trial for a rare disease: the trigeminal neuralgia experience", 
    "pagination": "704", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "8ad21b7b2a48940001a83458b45f8a2bf3c167b0b6baaad90dda382a438e0366"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "30587219"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "101263253"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/s13063-018-3045-1"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1110911708"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/s13063-018-3045-1", 
      "https://app.dimensions.ai/details/publication/pub.1110911708"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-11T08:31", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000309_0000000309/records_106280_00000000.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://link.springer.com/10.1186%2Fs13063-018-3045-1"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1186/s13063-018-3045-1'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/s13063-018-3045-1'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/s13063-018-3045-1'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/s13063-018-3045-1'


 

This table displays all metadata directly associated to this object as RDF triples.

221 TRIPLES      21 PREDICATES      48 URIs      21 LITERALS      9 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/s13063-018-3045-1 schema:about anzsrc-for:11
2 anzsrc-for:1103
3 schema:author N6dbdc90c9d424614b02e38523c998a1c
4 schema:citation sg:pub.10.1007/s12603-010-0009-x
5 sg:pub.10.1007/s40271-014-0096-6
6 sg:pub.10.1186/1745-6215-14-402
7 sg:pub.10.1186/1745-6215-7-9
8 sg:pub.10.1186/s13063-016-1322-4
9 https://app.dimensions.ai/details/publication/pub.1076799822
10 https://app.dimensions.ai/details/publication/pub.1082642225
11 https://doi.org/10.1002/ana.410270114
12 https://doi.org/10.1016/j.jclinepi.2010.02.007
13 https://doi.org/10.1016/j.pain.2006.01.030
14 https://doi.org/10.1016/j.pain.2008.03.002
15 https://doi.org/10.1016/j.pain.2009.08.023
16 https://doi.org/10.1016/s0895-4356(99)00141-9
17 https://doi.org/10.1016/s1474-4422(17)30005-4
18 https://doi.org/10.1097/j.pain.0000000000000853
19 https://doi.org/10.1111/head.12441
20 https://doi.org/10.1136/bmj.g6802
21 https://doi.org/10.1177/0333102413485658
22 https://doi.org/10.1177/0883073813495959
23 schema:datePublished 2018-12
24 schema:datePublishedReg 2018-12-01
25 schema:description BACKGROUND: This study aimed to describe recruitment challenges encountered during a phase IIa study of vixotrigine, a state and use-dependent Nav1.7 channel blocker, in individuals with trigeminal neuralgia. METHODS: This was an international, multicenter, placebo-controlled, randomized withdrawal study that included a 7-day run-in period, a 21-day open-label phase, and a 28-day double-blind phase in which patients (planned n = 30) were randomized to vixotrigine or placebo. Before recruitment, all antiepileptic drugs had to be stopped, except for gabapentin or pregabalin. After the trial, patients returned to their original medications. Patient recruitment was expanded beyond the original five planned (core) centers in order to meet target enrollment (total recruiting sites N = 25). Core sites contributed data related to patient identification for study participation (prescreening data). Data related to screening failures and study withdrawal were also analyzed using descriptive statistics. RESULTS: Approximately half (322/636; 50.6%) of the patients who were prescreened at core sites were considered eligible for the study and 56/322 (17.4%) were screened. Of those considered eligible, 26/322 (8.1%) enrolled in the study and 6/322 (1.9%) completed the study. In total, 125 patients were screened across all study sites and 67/125 (53.6%) were enrolled. At prescreening, reasons for noneligibility varied by site and were most commonly diagnosis change (78/314; 24.8%), age > 80 years (75/314; 23.9%), language/distance/mobility (61/314; 19.4%), and noncardiac medical problems (53/314; 16.9%). At screening, frequently cited reasons for noneligibility included failure based on electrocardiogram, insufficient pain, and diagnosis change. CONCLUSIONS: Factors contributing to recruitment challenges encountered in this study included diagnosis changes, anxiety over treatment changes, and issues relating to distance, language, and mobility. Wherever possible, future studies should be designed to address these challenges. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01540630 . EudraCT, 2010-023963-16. 07 Aug 2015.
26 schema:genre research_article
27 schema:inLanguage en
28 schema:isAccessibleForFree true
29 schema:isPartOf N33ab586ec6dc4a5b9a5656880186122e
30 Nf4212ef4ba9c46d787daf165e6ea7cc0
31 sg:journal.1297400
32 schema:name Challenges recruiting to a proof-of-concept pharmaceutical trial for a rare disease: the trigeminal neuralgia experience
33 schema:pagination 704
34 schema:productId N254e1c849e2042c7aa4bc53716201c41
35 N551176e44e294cb7af3c9bf32c141e53
36 N7268816f2e664258a005a00dd0ee6457
37 N9f4bc08129554cc7a8dc07badc4a1647
38 Nb6457df1562a4a2fba4038c8ca5c3245
39 schema:sameAs https://app.dimensions.ai/details/publication/pub.1110911708
40 https://doi.org/10.1186/s13063-018-3045-1
41 schema:sdDatePublished 2019-04-11T08:31
42 schema:sdLicense https://scigraph.springernature.com/explorer/license/
43 schema:sdPublisher Ncd14ae33dcbe44d7b7b9149b58df390b
44 schema:url https://link.springer.com/10.1186%2Fs13063-018-3045-1
45 sgo:license sg:explorer/license/
46 sgo:sdDataset articles
47 rdf:type schema:ScholarlyArticle
48 N051baac6814e412b8abae3bd177d50c9 rdf:first sg:person.01367274016.99
49 rdf:rest rdf:nil
50 N08babaa82f8b4265b923d4029352d8b6 schema:name Danish Headache Center, Department of Neurology, Rigshospitalet—Glostrup, University of Copenhagen, Valdemar Hansens Vej 5, 2600, Glostrup, Denmark
51 rdf:type schema:Organization
52 N0cf2a73fbf5b4ecc97dc7c00bb9c8b17 rdf:first sg:person.01121201055.34
53 rdf:rest Ne1e4bef2b02a48209e8a0b54a055b4be
54 N0f4e5156120e4b24b243243aaab36f0d rdf:first sg:person.01370442636.75
55 rdf:rest N2e477d5dc2f6421283789597655865cd
56 N254e1c849e2042c7aa4bc53716201c41 schema:name pubmed_id
57 schema:value 30587219
58 rdf:type schema:PropertyValue
59 N2e477d5dc2f6421283789597655865cd rdf:first sg:person.01253227442.40
60 rdf:rest Nd54d0af93a074d6baf4f551b09240fb1
61 N33ab586ec6dc4a5b9a5656880186122e schema:volumeNumber 19
62 rdf:type schema:PublicationVolume
63 N3c28eeb365a740c898663ef24850ca02 schema:name Danish Headache Center, Department of Neurology, Rigshospitalet—Glostrup, University of Copenhagen, Valdemar Hansens Vej 5, 2600, Glostrup, Denmark
64 rdf:type schema:Organization
65 N551176e44e294cb7af3c9bf32c141e53 schema:name doi
66 schema:value 10.1186/s13063-018-3045-1
67 rdf:type schema:PropertyValue
68 N67748ee8e53a4f17809afe2ec3f998e5 rdf:first sg:person.01331543222.87
69 rdf:rest N0f4e5156120e4b24b243243aaab36f0d
70 N6dbdc90c9d424614b02e38523c998a1c rdf:first sg:person.0605112763.04
71 rdf:rest N9b69921eb98e4e5cbc993820f419dc5e
72 N7268816f2e664258a005a00dd0ee6457 schema:name dimensions_id
73 schema:value pub.1110911708
74 rdf:type schema:PropertyValue
75 N80fe2fdb8d2142c6a08c1453184d02ac rdf:first sg:person.01303131547.72
76 rdf:rest N051baac6814e412b8abae3bd177d50c9
77 N9b69921eb98e4e5cbc993820f419dc5e rdf:first sg:person.014614064510.09
78 rdf:rest N0cf2a73fbf5b4ecc97dc7c00bb9c8b17
79 N9f4bc08129554cc7a8dc07badc4a1647 schema:name nlm_unique_id
80 schema:value 101263253
81 rdf:type schema:PropertyValue
82 Na9d3d7a1648e4eb6a51e972d95137e2b rdf:first sg:person.0622157744.24
83 rdf:rest N67748ee8e53a4f17809afe2ec3f998e5
84 Nb6457df1562a4a2fba4038c8ca5c3245 schema:name readcube_id
85 schema:value 8ad21b7b2a48940001a83458b45f8a2bf3c167b0b6baaad90dda382a438e0366
86 rdf:type schema:PropertyValue
87 Ncd14ae33dcbe44d7b7b9149b58df390b schema:name Springer Nature - SN SciGraph project
88 rdf:type schema:Organization
89 Nd54d0af93a074d6baf4f551b09240fb1 rdf:first sg:person.014424656727.95
90 rdf:rest N80fe2fdb8d2142c6a08c1453184d02ac
91 Ne1e4bef2b02a48209e8a0b54a055b4be rdf:first sg:person.0646714245.50
92 rdf:rest Na9d3d7a1648e4eb6a51e972d95137e2b
93 Nf4212ef4ba9c46d787daf165e6ea7cc0 schema:issueNumber 1
94 rdf:type schema:PublicationIssue
95 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
96 schema:name Medical and Health Sciences
97 rdf:type schema:DefinedTerm
98 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
99 schema:name Clinical Sciences
100 rdf:type schema:DefinedTerm
101 sg:journal.1297400 schema:issn 1468-6708
102 1745-6215
103 schema:name Trials
104 rdf:type schema:Periodical
105 sg:person.01121201055.34 schema:affiliation N3c28eeb365a740c898663ef24850ca02
106 schema:familyName Bendtsen
107 schema:givenName Lars
108 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01121201055.34
109 rdf:type schema:Person
110 sg:person.01253227442.40 schema:affiliation https://www.grid.ac/institutes/grid.476070.2
111 schema:familyName Morisset
112 schema:givenName Valerie
113 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01253227442.40
114 rdf:type schema:Person
115 sg:person.01303131547.72 schema:affiliation https://www.grid.ac/institutes/grid.476070.2
116 schema:familyName Tate
117 schema:givenName Simon
118 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01303131547.72
119 rdf:type schema:Person
120 sg:person.01331543222.87 schema:affiliation N08babaa82f8b4265b923d4029352d8b6
121 schema:familyName Maarbjerg
122 schema:givenName Stine
123 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01331543222.87
124 rdf:type schema:Person
125 sg:person.01367274016.99 schema:affiliation https://www.grid.ac/institutes/grid.7841.a
126 schema:familyName Cruccu
127 schema:givenName Giorgio
128 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01367274016.99
129 rdf:type schema:Person
130 sg:person.01370442636.75 schema:affiliation https://www.grid.ac/institutes/grid.5718.b
131 schema:familyName Obermann
132 schema:givenName Mark
133 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01370442636.75
134 rdf:type schema:Person
135 sg:person.014424656727.95 schema:affiliation https://www.grid.ac/institutes/grid.417832.b
136 schema:familyName Steiner
137 schema:givenName Deb
138 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014424656727.95
139 rdf:type schema:Person
140 sg:person.014614064510.09 schema:affiliation https://www.grid.ac/institutes/grid.476070.2
141 schema:familyName Palmer
142 schema:givenName Joanne
143 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014614064510.09
144 rdf:type schema:Person
145 sg:person.0605112763.04 schema:affiliation https://www.grid.ac/institutes/grid.52996.31
146 schema:familyName Zakrzewska
147 schema:givenName Joanna M.
148 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0605112763.04
149 rdf:type schema:Person
150 sg:person.0622157744.24 schema:affiliation https://www.grid.ac/institutes/grid.7400.3
151 schema:familyName Ettlin
152 schema:givenName Dominik A.
153 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0622157744.24
154 rdf:type schema:Person
155 sg:person.0646714245.50 schema:affiliation https://www.grid.ac/institutes/grid.7841.a
156 schema:familyName Di Stefano
157 schema:givenName Giulia
158 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0646714245.50
159 rdf:type schema:Person
160 sg:pub.10.1007/s12603-010-0009-x schema:sameAs https://app.dimensions.ai/details/publication/pub.1052693121
161 https://doi.org/10.1007/s12603-010-0009-x
162 rdf:type schema:CreativeWork
163 sg:pub.10.1007/s40271-014-0096-6 schema:sameAs https://app.dimensions.ai/details/publication/pub.1019482041
164 https://doi.org/10.1007/s40271-014-0096-6
165 rdf:type schema:CreativeWork
166 sg:pub.10.1186/1745-6215-14-402 schema:sameAs https://app.dimensions.ai/details/publication/pub.1016693421
167 https://doi.org/10.1186/1745-6215-14-402
168 rdf:type schema:CreativeWork
169 sg:pub.10.1186/1745-6215-7-9 schema:sameAs https://app.dimensions.ai/details/publication/pub.1045524118
170 https://doi.org/10.1186/1745-6215-7-9
171 rdf:type schema:CreativeWork
172 sg:pub.10.1186/s13063-016-1322-4 schema:sameAs https://app.dimensions.ai/details/publication/pub.1008710204
173 https://doi.org/10.1186/s13063-016-1322-4
174 rdf:type schema:CreativeWork
175 https://app.dimensions.ai/details/publication/pub.1076799822 schema:CreativeWork
176 https://app.dimensions.ai/details/publication/pub.1082642225 schema:CreativeWork
177 https://doi.org/10.1002/ana.410270114 schema:sameAs https://app.dimensions.ai/details/publication/pub.1014810421
178 rdf:type schema:CreativeWork
179 https://doi.org/10.1016/j.jclinepi.2010.02.007 schema:sameAs https://app.dimensions.ai/details/publication/pub.1039795884
180 rdf:type schema:CreativeWork
181 https://doi.org/10.1016/j.pain.2006.01.030 schema:sameAs https://app.dimensions.ai/details/publication/pub.1001039087
182 rdf:type schema:CreativeWork
183 https://doi.org/10.1016/j.pain.2008.03.002 schema:sameAs https://app.dimensions.ai/details/publication/pub.1035369935
184 rdf:type schema:CreativeWork
185 https://doi.org/10.1016/j.pain.2009.08.023 schema:sameAs https://app.dimensions.ai/details/publication/pub.1051817142
186 rdf:type schema:CreativeWork
187 https://doi.org/10.1016/s0895-4356(99)00141-9 schema:sameAs https://app.dimensions.ai/details/publication/pub.1015621495
188 rdf:type schema:CreativeWork
189 https://doi.org/10.1016/s1474-4422(17)30005-4 schema:sameAs https://app.dimensions.ai/details/publication/pub.1083849296
190 rdf:type schema:CreativeWork
191 https://doi.org/10.1097/j.pain.0000000000000853 schema:sameAs https://app.dimensions.ai/details/publication/pub.1074213391
192 rdf:type schema:CreativeWork
193 https://doi.org/10.1111/head.12441 schema:sameAs https://app.dimensions.ai/details/publication/pub.1036505399
194 rdf:type schema:CreativeWork
195 https://doi.org/10.1136/bmj.g6802 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020691613
196 rdf:type schema:CreativeWork
197 https://doi.org/10.1177/0333102413485658 schema:sameAs https://app.dimensions.ai/details/publication/pub.1004906592
198 rdf:type schema:CreativeWork
199 https://doi.org/10.1177/0883073813495959 schema:sameAs https://app.dimensions.ai/details/publication/pub.1053961422
200 rdf:type schema:CreativeWork
201 https://www.grid.ac/institutes/grid.417832.b schema:alternateName Biogen (United States)
202 schema:name Biogen, Cambridge, MA, USA
203 rdf:type schema:Organization
204 https://www.grid.ac/institutes/grid.476070.2 schema:alternateName Biogen (United Kingdom)
205 schema:name Convergence Pharmaceuticals Ltd, Cambridge, UK
206 rdf:type schema:Organization
207 https://www.grid.ac/institutes/grid.52996.31 schema:alternateName University College London Hospitals NHS Foundation Trust
208 schema:name Eastman Dental Hospital, 256 Gray’s Inn Road, London, UK
209 Facial Pain Unit, Division of Diagnostic, Surgical and Medical Sciences, Eastman Dental Hospital, University College London Hospitals NHS Foundation Trust/University College London, London, UK
210 Pain Management Centre, University College London Hospitals NHS Foundation Trust, London, UK
211 rdf:type schema:Organization
212 https://www.grid.ac/institutes/grid.5718.b schema:alternateName University of Duisburg-Essen
213 schema:name Center for Neurology, Asklepios Hospitals Schildautal, Seesen, Germany
214 Department of Neurology and German Headache Center, University of Duisburg-Essen, Essen, Germany
215 rdf:type schema:Organization
216 https://www.grid.ac/institutes/grid.7400.3 schema:alternateName University of Zurich
217 schema:name Interdisciplinary Orofacial Pain Unit, Clinic of Masticatory Disorders, Center of Dental Medicine, University of Zurich, Zurich, Switzerland
218 rdf:type schema:Organization
219 https://www.grid.ac/institutes/grid.7841.a schema:alternateName Sapienza University of Rome
220 schema:name Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy
221 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...