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
Secondary identifying numbers N0116149198
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

Department of Neurophysiology
Ruskin Wing
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectives1. 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) studiedNervous System Diseases: Epilepsy
InterventionDelayed withdrawal vs slow withdrawal
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)levetiracetam
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2004
Completion date01/12/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2004
Date of final enrolment01/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Neurophysiology
London
SE5 9RS
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Kings College Hospital NHS Trust R&D Consortium (UK)

No information available

NHS R&D support funding

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