Condition category
Nervous System Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
12/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes