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A randomised controlled trial of longer-term clinical outcomes and cost-effectiveness of Standard And New Antiepileptic Drugs
ISRCTN ISRCTN38354748
DOI 10.1186/ISRCTN38354748
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of longer-term clinical outcomes and cost-effectiveness of Standard And New Antiepileptic Drugs
Scientific title
Acronym SANAD
Serial number at source HTA 95/13/01
Study hypothesis We propose a pragmatic parallel group Randomised Controlled Trial (RCT) comparing monotherapy with clinicians' first choice standard drug (carbamazepine or valproate) versus appropriate comparators from among the new antiepileptic drugs.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Epilepsy
Participants - inclusion criteria Patients recently suffering seizures
Participants - exclusion criteria Not provided at time of registration.
Anticipated start date 01/09/1998
Anticipated end date 31/03/2006
Status of trial Completed
Patient information material
Target number of participants 3,000
Interventions Monotherapy with clinicians' first choice standard drug (carbamazepine or valproate) versus appropriate comparators from among the new antiepileptic drugs
Primary outcome measure(s) Primary outcomes will be retention time on randomised drug and time to one year remission of seizures.
Secondary outcome measure(s) Secondary outcomes will include psychosocial measures and impact on direct medical costs.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website http://www.liv.ac.uk/neuroscience/root/division%20of%20neurological%20science/research/sanad/index.htm
Publications 2007 valproate trial results in http://www.ncbi.nlm.nih.gov/pubmed/17382828
2007 carbamazepine trial results in http://www.ncbi.nlm.nih.gov/pubmed/17382827
2007 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/17903391
Contact name Prof  David  Chadwick
  Address Department of Neurological Science
The Walton Centre
Lower Lane
Fazakerley
  City/town Liverpool
  Zip/Postcode L9 7LJ
  Country United Kingdom
  Tel +44 (0)151 529 5461
  Fax +44 (0)151 529 5466
  Email dwc@liv.ac.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Tel +44 (0)1132 545 843
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 25/04/2003
Last edited 28/08/2009
Date ISRCTN assigned 25/04/2003
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