Indications for and consequences of antiepileptic drug withdrawal

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• 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
• 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

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