Contact information
Type
Scientific
Primary contact
Prof Pål Gulbrandsen
ORCID ID
Contact details
HØKH
Akershus University Hospital
Mail drawer 95
Lørenskog
1478
Norway
+47 (0) 67 92 94 61
pal.gulbrandsen@ahus.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
The regional committee for medical research ethics in Eastern Norway has approved the study protocol (reference: S-127/99-99044).
Study design
Randomised controlled double-blinded study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Carbamazepine, Valproate, Phenytoin, Lamotrigine and Phenobarbitol.
Primary outcome measures
1. Neuropsychological function, as measured by a battery of 15 tests
2. Seizures
Secondary outcome measures
1. Electrocardiogram (ECG)
2. Electroencephalogram (EEG)
3. Endocrine function
4. Quality of life
5. Blood lipid levels
Overall trial start date
01/09/1999
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160 (150-170)
Participant 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)
Recruitment start date
01/09/1999
Recruitment end date
31/03/2005
Locations
Countries of recruitment
Norway
Trial participating centre
HØKH
Lørenskog
1478
Norway
Sponsor information
Organisation
Akershus University Hospital (Norway)
Sponsor details
Mail drawer 95
Lørenskog
1478
Norway
+47 (0) 67 92 92 35
geir.bukholm@ahus.no
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Akershus University Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Norwegian Foundation for Health and Rehabilitation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Extra funding is received from:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Norwegian Epilepsy Association
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Norwegian Chapter of the International League against Epilepsy
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Helse Øst Regional Health Authorities
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foundation for Health Services Research (HELTEF)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The various active drugs and placebo tablets were provided by Glaxo SmithKline, Desitin and Novartis
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17888074
Publication citations
-
Results
Lossius MI, Hessen E, Mowinckel P, Stavem K, Erikssen J, Gulbrandsen P, Gjerstad L, Consequences of antiepileptic drug withdrawal: a randomized, double-blind study (Akershus Study)., Epilepsia, 2008, 49, 3, 455-463, doi: 10.1111/j.1528-1167.2007.01323.x.