Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00438451
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2007-02-21
Brief Title:
Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Johannes Gutenberg University Mainz
Study Overview
Official Title:
A Multicentre Double-blind Randomized Phase IV Clinical Trial Comparing the Safety Tolerability and Efficacy of Levetiracetam Versus Lamotrigine and Carbamazepine in the Oral Antiepileptic Therapy of Newly Diagnosed Elderly Patients With Focal Epilepsy
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
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:
STEP-ONE
Brief Summary:
In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind randomized design over a period of 58 weeks All drugs are licensed for the treatment of epilepsy The primary endpoint of this study will be retention rate at 58-weeks since it reflects both efficacy and tolerability
Detailed Description:
Indication Focal Epilepsy Objectives To evaluate the tolerability and efficacy of levetiracetam LEV in newly diagnosed elderly patients aged 60 yrs or above with focal epilepsy compared to lamotrigine LTG or carbamazepine slow release CBZ
Primary Outcome The primary outcome will be the 58-week retention rate measured by the number of drop outs due to adverse events or seizures from day 1 of treatment
Secondary Outcome Proportion of patients remaining seizure-free at week 30 Visit 4 proportion of patients remaining seizure free at week 58 Visit 6 the time in days to first break-through seizure from day 1 of treatment the absolute seizure frequency during the maintenance over 52 weeks phase proportion of seizure-free days during the maintenance phase for subjects who enter the maintenance phase the frequency of adverse events from day 1 of treatment QOLIE-31 results at V6 Portland Neurotoxicity scale at V6 results of cognitive testing EpiTrack by UCB
Trial Design This is a randomized double-blind multicenter Phase IV study using a parallel group design with three treatment groups The study will consist of a 6-week titration-phase and a 52-week maintenance phase Patients who successfully complete the trial final visit V6 will be unblinded and offered either to continue on their current drug or be changed to an alternative antiepileptic drug AED treatment of choice
Population Patients aged 60 years or above with new onset focal epilepsy ie either at least one epileptic seizure in the last 6 months and focal epileptiform discharges on EEG or a relevant lesion on CTMRI or a total of 2 epileptic seizures one of which occurring in the last 6 months prior inclusion Patients with acute 2 weeks symptomatic epileptic seizures due to acute brain abnormalities ie haemorrhage or cerebral infarct or contraindications against any of the drugs in trial will be excluded
Sample Size 360 patients to be included 120 patients per treatment arm Investigational Medicinal Products Levetiracetam lamotrigine carbamazepine-slow release Trial Duration and Dates Duration of treatment 6 weeks titration phase 52 weeks maintenance phase
Follow up At the end of trial subjects will be unblinded and may choose to continue on the medication or taper the trial medication and be treated with an alternative drug at the investigators discretion The patient will receive a dosing schedule and a referral letter for hisher physician
Duration of trial approximately 2 years Start of recruitment January 2007 Projected number of centres 75 Number of countries 3 Germany Switzerland Austria
Primary Outcome The primary outcome will be the 58-week retention rate measured by the number of drop outs due to adverse events or seizures from day 1 of treatment
Secondary Outcome Proportion of patients remaining seizure-free at week 30 Visit 4 proportion of patients remaining seizure free at week 58 Visit 6 the time in days to first break-through seizure from day 1 of treatment the absolute seizure frequency during the maintenance over 52 weeks phase proportion of seizure-free days during the maintenance phase for subjects who enter the maintenance phase the frequency of adverse events from day 1 of treatment QOLIE-31 results at V6 Portland Neurotoxicity scale at V6 results of cognitive testing EpiTrack by UCB
Trial Design This is a randomized double-blind multicenter Phase IV study using a parallel group design with three treatment groups The study will consist of a 6-week titration-phase and a 52-week maintenance phase Patients who successfully complete the trial final visit V6 will be unblinded and offered either to continue on their current drug or be changed to an alternative antiepileptic drug AED treatment of choice
Population Patients aged 60 years or above with new onset focal epilepsy ie either at least one epileptic seizure in the last 6 months and focal epileptiform discharges on EEG or a relevant lesion on CTMRI or a total of 2 epileptic seizures one of which occurring in the last 6 months prior inclusion Patients with acute 2 weeks symptomatic epileptic seizures due to acute brain abnormalities ie haemorrhage or cerebral infarct or contraindications against any of the drugs in trial will be excluded
Sample Size 360 patients to be included 120 patients per treatment arm Investigational Medicinal Products Levetiracetam lamotrigine carbamazepine-slow release Trial Duration and Dates Duration of treatment 6 weeks titration phase 52 weeks maintenance phase
Follow up At the end of trial subjects will be unblinded and may choose to continue on the medication or taper the trial medication and be treated with an alternative drug at the investigators discretion The patient will receive a dosing schedule and a referral letter for hisher physician
Duration of trial approximately 2 years Start of recruitment January 2007 Projected number of centres 75 Number of countries 3 Germany Switzerland Austria
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT Number2005-003324-19 | None | None | None |
| ISRCTN 94839639 | None | None | None |