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 |
| Protocol serial number | HTA 95/13/01 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Scientific
Department of Neurological Science
The Walton Centre
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom
| Phone | +44 (0)151 529 5461 |
|---|---|
| dwc@liv.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Carbamazepine, valproate |
| Primary outcome measure(s) | Primary outcomes will be retention time on randomised drug and time to one year remission of seizures. |
| Key secondary outcome measure(s) | Secondary outcomes will include psychosocial measures and impact on direct medical costs. |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 3000 |
| 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
- United Kingdom
- England
Study participating centre
The Walton Centre
Liverpool
L9 7LJ
United Kingdom
L9 7LJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Results article | results | 01/03/2015 | Yes | No | |
| Results article | results | 01/04/2019 | Yes | No | |
| Other publications | HTA monograph | 01/10/2007 | 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.
