Reduction of concomitant antiepileptic medication after successful treatment with levetiracetam; a randomised open label study comparing delayed withdrawal to slow withdrawal.
| ISRCTN | ISRCTN72533351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72533351 |
| Protocol serial number | N0116149198 |
| Sponsor | Department of Health |
| Funders | Kings College Hospital NHS Trust R&D Consortium (UK), NHS R&D support funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 14/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr RDC Elwes
Scientific
Scientific
Department of Neurophysiology
Ruskin Wing
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. To assess the potential of levetiracetam monotherapy in chronic epilepsy. 2. To compare the effects of withdrawal of concomitant antiepileptic drug seizure frequency and severity, drug toxicity and quality of life with a randomised control group remaining on Levetiracetam |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Epilepsy |
| Intervention | Delayed withdrawal vs slow withdrawal |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | levetiracetam |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Neurophysiology
London
SE5 9RS
United Kingdom
SE5 9RS
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 |
