Condition category
Nervous System Diseases
Date applied
30/06/2006
Date assigned
17/08/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ahus.no/modules/module_123/proxy.asp?iDisplayType=2&iCategoryId=474&iInfoId=2906&mids=1034

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

  1. 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.

Additional files

Editorial Notes