A multicentre, double-blind, randomised, 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

Phase 4

Completed

• Conditions: ewly diagnosed focal epilepsy; Nervous System Diseases; Focal epilepsy

• Registration Number: ISRCTN94839639
• Lead Sponsor: niversity of Mainz Medical Faculty (Germany)

Brief Summary

2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25684224 (added 11/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-12
• Study Completion: 2008-10-30
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Aged 60 years or above
2. New onset focal epilepsy (either at least one epileptic seizure in the last six months and focal epileptiform discharges on electroencephalogram (EEG) or a relevant lesion on computed tomography (CT)/magnetic resonance imaging (MRI) or at least two epileptic seizures, one of which occurred in the last six months prior inclusion)
3. No previous anti-epileptic drug (AED) treatment, except for a period not longer than four weeks prior to inclusion (V0)
4. Ability of subject to understand verbal and written instructions, to comply with all study requirements, and to comprehend character and individual consequences of the clinical trial
5. Written informed consent before enrolment in the trial

Exclusion Criteria

Subjects presenting with any of the following criteria will not be included in the trial:
1. Acute symptomatic epileptic seizures occurring acutely within a two week period after the onset of an acute illness such as cerebral haemorrhage, cerebral infarct, rapid progressive malignancy or other acute brain abnormalities (i.e. encephalitis, hypoxic brain damage, trauma, metabolic derangement, following brain surgery)
2. Dementia (as defined by history)
3. Renal insufficiency as defined by glomerular filtration rate (GFR) less than 50 ml/min
4. Increased liver enzymes (glutamic-oxaloacetic transaminase [GOT], glutamic-pyruvic transaminase [GPT], gamma-glutamyl-transferase [gGT]) or increased bilirubin more than or equal to twofold the upper limit of normal (ULN)
5. Pre-treatment with valproic acid within the four weeks prior inclusion (V0)
6. Contraindication against or history of hypersensitivity to any of the investigational medicinal products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products
7. Participation in other clinical trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified