Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133081
Status:
UNKNOWN
Last Update Posted:
2005-10-21
First Post:
2005-08-17
Brief Title:
Study to Improve the Treatment of Epilepsy SITE
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Study to Improve the Treatment of Epilepsy SITE A Randomized Study Comparing Adjustment of Treatment to Reduce Side Effects of Antiepileptic Drugs With Continuing Treatment Unchanged
Status:
UNKNOWN
Status Verified Date:
2004-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess whether changing antiepileptic medication can reduce side effects and improve the quality of life in patients with epileptic seizures that are well controlled with antiepileptic drugs
Detailed Description:
Background The aim of the treatment with antiepileptic drugs AEDs is to achieve seizure freedom without causing side effects Assessment of side effects is difficult They may start insidiously the patient may not associate certain complaints with the use of AEDs or the treating physician does not take enough time to discuss this topic during the limited time of a visit in the outpatient department We know from clinical trials that side effects occur in a substantial group of patients We do not know whether we deal with this possible complication in an adequate way in clinical practice
Study objective To study whether adjustment of medication will reduce the occurrence of side effects and improve quality of life
Study design A randomised clinical trial comparing adjustment of treatment in case of relevant side effects to continuing treatment unchanged Relevant side effects are defined as at least one moderate or serious problem scored on a questionnaire to assess complaints in people with epilepsy
Patients who do not report relevant side effects will be followed for 13 months arm A in which two visits are scheduled after 7 and 13 months respectively
The patients who do report relevant side effects will be randomised to either discussion of the questionnaire results and adjustment of treatment if appropriate arm B or to ignore the results of the questionnaire and continue treatment unchanged arm C Investigations will be repeated in both groups after 7 and 13 months after the initial visit
Study objective To study whether adjustment of medication will reduce the occurrence of side effects and improve quality of life
Study design A randomised clinical trial comparing adjustment of treatment in case of relevant side effects to continuing treatment unchanged Relevant side effects are defined as at least one moderate or serious problem scored on a questionnaire to assess complaints in people with epilepsy
Patients who do not report relevant side effects will be followed for 13 months arm A in which two visits are scheduled after 7 and 13 months respectively
The patients who do report relevant side effects will be randomised to either discussion of the questionnaire results and adjustment of treatment if appropriate arm B or to ignore the results of the questionnaire and continue treatment unchanged arm C Investigations will be repeated in both groups after 7 and 13 months after the initial visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None