Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

Epilepsy Clinical Trial

Official title:

An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896987
• Other study ID #: 106172
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2009
• Last updated: May 11, 2009
• Start date: May 2006
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• Source: Korean Epilepsy Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of anti-epileptic drugs' (AEDs) long-term treatment on cognitive function. This study is an open-label, randomized, multicenter comparative trial of lamotrigine versus carbamazepine. The planned enrollment is 100 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age : 16~60

• Seizure type was defined by MRI etc.

• Had more than 2 unprovoked seizures or 1 seizure with clear evidence for epilepsy (ex. positive in EEG or brain imaging)

• Need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2 weeks, baseline 4 weeks before)

• Is not pregnant by pregnancy test and is using contraceptive method

• Can report seizure diary by him/herself or his/her sick nurse

• Agreed to trial by written consent

Exclusion Criteria:

• Follow-up loss

• Canceled agreement

• Added other medication due to aggravated disease in 24 weeks

• Diagnosed as IGE

• Has progressive CNS disease by MRI or EEG

• Has serious systemic or psychological disease

• Under IQ 70

• Baseline lad data abnormality: Creatinine 2.0mg/dl or GOT/GPT 2 times higher than normal

• Abuse experience on alcohol or drugs

• Has experience on serious adverse event of any drug

• Previous experience on lamotrigine or carbamazepine

• Not suitable patients by investigator (uncooperative)

• Other reason which may interrupt the trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• lamotrigine (Lamictal)
lamotrigine: titration for 8 weeks (25 mg~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)
• Carbamazepine (Tegretol)
Carbamazepine: titration for 8 weeks (100 mg~600 mg) and maintenance for 40 weeks (600 mg)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korean Epilepsy Society	GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients		48 weeks	Yes
Secondary	Seizure outcome and tolerability		48 weeks	Yes