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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 30 June 2014
Main ID:  ISRCTN28271641
Date of registration: 17/08/2006
Primary sponsor: Akershus University Hospital (Norway)
Public title: Indications for and consequences of antiepileptic drug withdrawal N/A
Scientific title:
Date of first enrolment: Sep 1 1999
Target sample size: 160 (150-170)
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN28271641
Study type:  Interventional
Study design:  Randomised controlled double-blinded study  
Countries of recruitment
Norway
Contacts
Name: Pål  Gulbrandsen
Address:  HØKH Akershus University Hospital Mail drawer 95 1478 Lørenskog Norway
Telephone: +47 (0) 67 92 94 61
Email: pal.gulbrandsen@ahus.no
Affiliation: 
Key inclusion & exclusion criteria
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

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)


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Epilepsy
Intervention(s)
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.
Primary Outcome(s)
1. Neuropsychological function, as measured by a battery of 15 tests
2. Seizures
Secondary Outcome(s)
1. Electrocardiogram (ECG)
2. Electroencephalogram (EEG)
3. Endocrine function
4. Quality of life
5. Blood lipid levels
Secondary ID(s)
N/A
Source(s) of Monetary Support
1. Akershus University Hospital 2. The Norwegian Foundation for Health and Rehabilitation Extra funding is received from: 1. Norwegian Epilepsy Association 2. Norwegian Chapter of the International League against Epilepsy 3. Helse Øst Regional Health Authorities 4. Foundation for Health Services Research (HELTEF) The various active drugs and placebo tablets were provided by Glaxo SmithKline, Desitin and Novartis
Secondary Sponsor(s)
N/A
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