Lamotrigine Cognitive Function Study in Adult Untreated E... | NCT00896987

Studies
Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

NCT00896987

Sponsor

Korean Epilepsy Society

Status

Completed

Last Update Posted

May 12, 2009Estimated

Enrollment

121Actual

Phase

Phase 4

Conditions

Epilepsy

Interventions

lamotrigine (Lamictal)
Carbamazepine (Tegretol)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

May 11, 2009

First Submission Date that Met QC Criteria

May 11, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2009

Last Update Posted Date

May 12, 2009Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	lamotrigine	Drug: lamotrigine (Lamictal)
2	Active Comparator	carbamazepine	Drug: Carbamazepine (Tegretol)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lamotrigine (Lamictal)	Drug	lamotrigine: titration for 8 weeks (25 mg~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients		48 weeks

Secondary Outcomes

Measure	Description	Time Frame
Seizure outcome and tolerability		48 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sang-Ahm Lee, Professor	Asan Medical Center	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077213	Lamotrigine
D002220	Carbamazepine

Ancestor Terms

ID	Term
D014227	Triazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D003984	Dibenzazepines

Browse Leaves

Not provided

Browse Branches

Not provided