A randomised controlled trial of longer-term clinical outcomes and cost-effectiveness of Standard And New Antiepileptic Drugs

ISRCTN ISRCTN38354748
DOI https://doi.org/10.1186/ISRCTN38354748
Secondary identifying numbers HTA 95/13/01
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
14/04/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Chadwick
Scientific

Department of Neurological Science
The Walton Centre
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom

Phone +44 (0)151 529 5461
Email dwc@liv.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA randomised controlled trial of longer-term clinical outcomes and cost-effectiveness of Standard And New Antiepileptic Drugs
Study acronymSANAD
Study objectivesWe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedEpilepsy
InterventionMonotherapy with clinicians' first choice standard drug (carbamazepine or valproate) versus appropriate comparators from among the new antiepileptic drugs
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Carbamazepine, valproate
Primary outcome measurePrimary outcomes will be retention time on randomised drug and time to one year remission of seizures.
Secondary outcome measuresSecondary outcomes will include psychosocial measures and impact on direct medical costs.
Overall study start date01/09/1998
Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants3,000
Total final enrolment2437
Key inclusion criteriaPatients recently suffering seizures
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/09/1998
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Walton Centre
Liverpool
L9 7LJ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article carbamazepine trial results 24/03/2007 Yes No
Results article valproate trial results 24/03/2007 Yes No
Other publications HTA monograph 01/10/2007 Yes No
Results article results 01/03/2015 Yes No
Results article results 01/04/2019 Yes No

Editorial Notes

14/04/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2007 references.