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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A randomised controlled trial of longer-term clinical outcomes and cost-effectiveness of Standard And New Antiepileptic Drugs
Study acronym	SANAD
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Epilepsy
Intervention	Monotherapy with clinicians' first choice standard drug (carbamazepine or valproate) versus appropriate comparators from among the new antiepileptic drugs
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Carbamazepine, valproate
Primary outcome measure	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 study start date	01/09/1998
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	3,000
Total final enrolment	2437
Key inclusion criteria	Patients recently suffering seizures
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/09/1998
Date of final enrolment	31/03/2006

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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.