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