Indications for and consequences of antiepileptic drug withdrawal

ISRCTN	ISRCTN28271641
DOI	https://doi.org/10.1186/ISRCTN28271641
Protocol serial number	N/A
Sponsor	Akershus University Hospital (Norway)
Funders	Akershus University Hospital, The Norwegian Foundation for Health and Rehabilitation, Extra funding is received from:, Norwegian Epilepsy Association, Norwegian Chapter of the International League against Epilepsy, Helse Øst Regional Health Authorities, Foundation for Health Services Research (HELTEF), The various active drugs and placebo tablets were provided by Glaxo SmithKline, Desitin and Novartis

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Pål Gulbrandsen
Scientific

HØKH
Akershus University Hospital
Mail drawer 95
Lørenskog
1478
Norway

Phone	+47 (0) 67 92 94 61
Email	pal.gulbrandsen@ahus.no

Primary study design	Interventional
Study design	Randomised controlled double-blinded study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	We will investigate predictors for remission of seizures after Anti-Epileptic Drug (AED) withdrawal. We also will monitor: seizure frequency, cardiovascular function, hormonal function, cognitive function, quality of life, and Electroencephalogram (EEG).
Ethics approval(s)	The regional committee for medical research ethics in Eastern Norway has approved the study protocol (reference: S-127/99-99044).
Health condition(s) or problem(s) studied	Epilepsy
Intervention	The patients were block-randomised (in blocks of ten) to receive blindly either active medication or placebo in pre-packed dispensers (Dosett), one for each of the 12 withdrawal weeks. Those randomised to withdrawal had AED dose reduction by 20 percent the first six weeks and 20 percent every second week until week 12. The reduced medication was substituted with a placebo to keep the study double blinded.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Carbamazepine, Valproate, Phenytoin, Lamotrigine and Phenobarbitol.
Primary outcome measure(s)	1. Neuropsychological function, as measured by a battery of 15 tests 2. Seizures
Key secondary outcome measure(s)	1. Electrocardiogram (ECG) 2. Electroencephalogram (EEG) 3. Endocrine function 4. Quality of life 5. Blood lipid levels
Completion date	31/03/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	160
Key inclusion criteria	1. Epilepsy (minimum of two unprovoked epileptic fits) 2. Two year seizure freedom 3. Only one antiepileptic drug in use 4. Aged 18 to 67 years
Key exclusion criteria	1. Juvenile myoclonus epilepsy 2. Paroxysmal EEG activity before termination of treatment, in patients with primary generalized epilepsy 3. Using several AEDs 4. Pregnancy 5. Mental retardation 6. Progressive neurological disease 7. Other known condition, which may affect patient's condition during follow-up 8. Other permanent medication (except in the case of contraceptive pills and hormonal treatment for menopausal conditions)
Date of first enrolment	01/09/1999
Date of final enrolment	31/03/2005

HØKH

Lørenskog
1478
Norway

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	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2008		Yes	No