Indications for and consequences of antiepileptic drug withdrawal
| ISRCTN | ISRCTN28271641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28271641 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/06/2006
- Registration date
- 17/08/2006
- Last edited
- 25/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Pål Gulbrandsen
Scientific
Scientific
HØKH
Akershus University Hospital
Mail drawer 95
Lørenskog
1478
Norway
| Phone | +47 (0) 67 92 94 61 |
|---|---|
| pal.gulbrandsen@ahus.no |
Study information
| Study design | Randomised controlled double-blinded study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Carbamazepine, Valproate, Phenytoin, Lamotrigine and Phenobarbitol. |
| Primary outcome measure | 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 study start date | 01/09/1999 |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 (150-170) |
| 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 |
Locations
Countries of recruitment
- Norway
Study participating centre
HØKH
Lørenskog
1478
Norway
1478
Norway
Sponsor information
Akershus University Hospital (Norway)
Hospital/treatment centre
Hospital/treatment centre
Mail drawer 95
Lørenskog
1478
Norway
| Phone | +47 (0) 67 92 92 35 |
|---|---|
| geir.bukholm@ahus.no | |
| Website | http://www.ahus.no/modules/module_123/proxy.asp?iDisplayType=2&iCategoryId=474&iInfoId=2906&mids=1034 |
"ROR" |
https://ror.org/0331wat71 |
Funders
Funder type
University/education
Akershus University Hospital
No information available
The Norwegian Foundation for Health and Rehabilitation
No information available
Extra funding is received from:
No information available
Norwegian Epilepsy Association
No information available
Norwegian Chapter of the International League against Epilepsy
No information available
Helse Øst Regional Health Authorities
No information available
Foundation for Health Services Research (HELTEF)
No information available
The various active drugs and placebo tablets were provided by Glaxo SmithKline, Desitin and Novartis
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2008 | Yes | No |
