Multicentre study of early Epilepsy and Single Seizures

ISRCTN	ISRCTN98767960
DOI	https://doi.org/10.1186/ISRCTN98767960
Protocol serial number	G9125371
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MESS
Study objectives	1. To compare seizure recurrence rates associated with policies of immediate or delayed antiepileptic drug therapy in patients with single seizures and early epilepsy using a pragmatic randomized parallel group design. 2. To identify factors of prognostic importance in the recurrence of seizures in the early course of epilepsy 3. To examine the psychosocial outcome of the two randomized policies
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Epilepsy
Intervention	Immediate/delayed antiepileptic drug therapy
Intervention type	Other
Primary outcome measure(s)	Time to first seizure, time to remission, patient perceived quality of life
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2002

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1800
Key inclusion criteria	1. An adequately documented recent history of one or more clinically definite spontaneous unprovoked epileptic seizures 2. Clinician is uncertain whether to treat or not
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1993
Date of final enrolment	31/12/2002

Department of Neurological Science

Liverpool
L9 7LJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/06/2005	Yes	No
Results article	results	01/04/2006	Yes	No
Results article	results	28/11/2006	Yes	No
Results article	results	07/12/2010	Yes	No
Results article	results	01/08/2012	Yes	No