Contact information
Type
Scientific
Primary contact
Prof David Chadwick
ORCID ID
Contact details
Department of Neurological Science
The Walton Centre
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom
+44 (0)151 529 5461
dwc@liv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 95/13/01
Study information
Scientific title
A randomised controlled trial of longer-term clinical outcomes and cost-effectiveness of Standard And New Antiepileptic Drugs
Acronym
SANAD
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.
More details can be found at http://www.nets.nihr.ac.uk/projects/hta/951301
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Epilepsy
Intervention
Monotherapy with clinicians' first choice standard drug (carbamazepine or valproate) versus appropriate comparators from among the new antiepileptic drugs
Intervention type
Drug
Phase
Not Applicable
Drug names
Carbamazepine, valproate
Primary outcome measures
Primary outcomes will be retention time on randomised drug and time to one year remission of seizures.
Secondary outcome measures
Secondary outcomes will include psychosocial measures and impact on direct medical costs.
Overall trial start date
01/09/1998
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients recently suffering seizures
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
3,000
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/09/1998
Recruitment end date
31/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Walton Centre
Liverpool
L9 7LJ
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25630353
Publication citations
-
HTA monograph
Marson AG, Appleton R, Baker GA, Chadwick DW, Doughty J, Eaton B, Gamble C, Jacoby A, Shackley P, Smith DF, Tudur-Smith C, Vanoli A, Williamson PR, A randomised controlled trial examining the longer-term outcomes of standard versus new antiepileptic drugs. The SANAD trial., Health Technol Assess, 2007, 11, 37, iii-iv, ix-x, 1-134.
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Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, Cramp C, Cockerell OC, Cooper PN, Doughty J, Eaton B, Gamble C, Goulding PJ, Howell SJ, Hughes A, Jackson M, Jacoby A, Kellett M, Lawson GR, Leach JP, Nicolaides P, Roberts R, Shackley P, Shen J, Smith DF, Smith PE, Smith CT, Vanoli A, Williamson PR, , The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial., Lancet, 2007, 369, 9566, 1016-1026, doi: 10.1016/S0140-6736(07)60461-9.
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Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, Cramp C, Cockerell OC, Cooper PN, Doughty J, Eaton B, Gamble C, Goulding PJ, Howell SJ, Hughes A, Jackson M, Jacoby A, Kellett M, Lawson GR, Leach JP, Nicolaides P, Roberts R, Shackley P, Shen J, Smith DF, Smith PE, Smith CT, Vanoli A, Williamson PR, , The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial., Lancet, 2007, 369, 9566, 1000-1015, doi: 10.1016/S0140-6736(07)60460-7.
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Results
Jacoby A, Sudell M, Tudur Smith C, Crossley J, Marson AG, Baker GA; SANAD Study Group, Quality-of-life outcomes of initiating treatment with standard and newer antiepileptic drugs in adults with new-onset epilepsy: findings from the SANAD trial, Epilepsia, 2015 , 56, 3, 460-472, doi: 10.1111/epi.12913.