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| [ Print-friendly version ] |
| Indications for and consequences of antiepileptic drug withdrawal |
| ISRCTN | ISRCTN28271641 |
| ClinicalTrials.gov identifier | |
| Public title | Indications for and consequences of antiepileptic drug withdrawal |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| 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). |
| Lay summary | |
| 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 |
| Countries of recruitment | Norway |
| Disease/condition/study domain | Epilepsy |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/09/1999 |
| Anticipated end date | 31/03/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 160 (150-170) |
| Interventions | 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 measure(s) |
1. Neuropsychological function, as measured by a battery of 15 tests
2. Seizures |
| Secondary outcome measure(s) |
1. Electrocardiogram (ECG)
2. Electroencephalogram (EEG) 3. Endocrine function 4. Quality of life 5. Blood lipid levels |
| Sources of funding |
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 |
| Trial website | |
| Publications | 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17888074 |
| Contact name | Prof Pål Gulbrandsen |
| Address |
HØKH
Akershus University Hospital Mail drawer 95 |
| City/town | Lørenskog |
| Zip/Postcode | 1478 |
| Country | Norway |
| Tel | +47 (0) 67 92 94 61 |
| Fax | +47 (0) 67 92 94 69 |
| pal.gulbrandsen@ahus.no | |
| Sponsor | Akershus University Hospital (Norway) |
| Address | Mail drawer 95 |
| City/town | Lørenskog |
| Zip/Postcode | 1478 |
| Country | Norway |
| Tel | +47 (0) 67 92 92 35 |
| Fax | +47 (0) 67 92 94 69 |
| geir.bukholm@ahus.no | |
| Sponsor website: | http://www.ahus.no/modules/module_123/proxy.asp?iDisplayType=2&iCategoryId=474&iInfoId=2906&mids=1034 |
| Date applied | 30/06/2006 |
| Last edited | 25/09/2009 |
| Date ISRCTN assigned | 17/08/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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