Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs

NCT00438451 | Completed Phase 4 Results

• 3 other identifiers: STEPONE05ISRCTN: 94839639EudraCT Number:2005-003324-19
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 1

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.

Conditions

Focal Epilepsy

Keywords

elderly; focal epilepsy; anticonvulsive; treatment; levetiracetam; lamotrigine; carbamazepine

Outcome Measures

Primary Outcomes (1)

• 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment

  58 weeks

Secondary Outcomes (11)

• Time to Drop Out

  58 weeks

• Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)

  Week 30

• Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)

  week 58

• The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)

  over the whole duration of 58 weeks

• The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)

  over 52 weeks

Study Arms (3)

Levetiracetam

ACTIVE COMPARATOR

Levetiracetam

Drug: Levetiracetam

Carbamazepine

ACTIVE COMPARATOR

Carbamazepine

Drug: Carbamazepine

Lamotrigine

ACTIVE COMPARATOR

Lamotrigine

Drug: Lamotrigine

Interventions

Levetiracetam DRUG

LEV 250 mg capusles: week 1 and 2 0-0-1, week 3 and 4 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (500 - 3000 mg)during maintenance.

Levetiracetam

Carbamazepine DRUG

CBZ 100 mg capusles: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (200 - 1200 mg) during maintenance depending on tolerance and efficacy.

Carbamazepine

Lamotrigine DRUG

LTG 25 mg encapsulated: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 caps. per day (50 - 300 mg)during maintenance depending on tolerance and efficacy.

Lamotrigine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 yrs or above.
• 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.
• Written informed consent before enrolment in the trial.

You may not qualify if:

• Acute symptomatic epileptic seizures occurring acutely within a 2 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).
• Dementia (as defined by history)
• Renal insufficiency as defined by GFR \< 50 mL/min.
• Increased liver enzymes (GOT, GPT, gGT) or increased bilirubin ≥ 2-fold the upper limit of normal (ULN).
• 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.
• Participation in other clinical trials and observation period of competing trials within the last 2 months, respectively.
• History of drug or alcohol abuse within the last 2 years.
• Medical condition which interferes with the participation in the trial according to the opinion of the investigator.
• Patients with life expectancy \< 1 year due to malignant disease
• Psychiatric morbidity requiring legal guardianship.

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• UCB Pharma GmbH: collaborator

Study Sites (1)

Department of Neurology, University of Mainz Medical Centre

Mainz, 55101, Germany

Location

Related Publications (3)

• Rowan AJ, Ramsay RE, Collins JF, Pryor F, Boardman KD, Uthman BM, Spitz M, Frederick T, Towne A, Carter GS, Marks W, Felicetta J, Tomyanovich ML; VA Cooperative Study 428 Group. New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine. Neurology. 2005 Jun 14;64(11):1868-73. doi: 10.1212/01.WNL.0000167384.68207.3E.

  PMID: 15955935 BACKGROUND

• Brodie MJ, Chadwick DW, Anhut H, Otte A, Messmer SL, Maton S, Sauermann W, Murray G, Garofalo EA; Gabapentin Study Group 945-212. Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. Epilepsia. 2002 Sep;43(9):993-1000. doi: 10.1046/j.1528-1157.2002.45401.x.

  PMID: 12199724 BACKGROUND

• Werhahn KJ, Trinka E, Dobesberger J, Unterberger I, Baum P, Deckert-Schmitz M, Kniess T, Schmitz B, Bernedo V, Ruckes C, Ehrlich A, Kramer G. A randomized, double-blind comparison of antiepileptic drug treatment in the elderly with new-onset focal epilepsy. Epilepsia. 2015 Mar;56(3):450-9. doi: 10.1111/epi.12926. Epub 2015 Feb 12.

  PMID: 25684224 DERIVED

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Levetiracetam; Carbamazepine; Lamotrigine

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Triazines

Results Point of Contact

• Title: C. Ruckes
• Organization: Interdisciplinary Center for Clinical Trials (IZKS Mainz)

ruckes@izks-mainz.de

+49 (0) 6131 17

Study Officials

• Konrad J Werhahn, MD

  Johannes Gutenberg University, Department od Neurology

  STUDY CHAIR

• Günter Kraemer, MD

  Swiss Epilepy Centre

  STUDY DIRECTOR

• Eugen Trinka, MD

  Medical University of Salzburg, Department of Neurology, Austria

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Neurology, Head Section on Epilepsy

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: February 22, 2007
• Study Start: January 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2011
• Last Updated: February 28, 2013
• Results First Posted: February 28, 2013

Record last verified: 2013-01

Locations

DE (1)