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The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Carbamazepine

Lamotrigine/Valproate

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥16yr old
Who are diagnosed as epilepsy definitely
Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months
Who need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2weeks)
Who is not pregnant
Who can report seizure diary by him/herself or caregiver
Who agree to this trial and provide informed consent.
Type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial motor seizures;

Exclusion Criteria:

Who has progressive CNS disease.
Has serious systemic or psychiatric disease
Who is not suitable by investigator(uncooperative)
Who can not fill up diary check card
Is pregnant, breastfeeding, or planning to become pregnant
Exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other substance abusers, mental retardation etc.
Who cancels to agree to this trial and provide informed consent.
ALT, AST, bilirubin and BUN/Cr levels are more than twice normal range of them
WBC value is 2000 and less, Hb value is 9.0 and less, platelet count is 100,000 and less in CBC
Who took investigation products before participating this study

Sites / Locations

Yonsei Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Carbamazepine

Lamotrigine/Valproate

Arm Description

Carbamazepine

Lamotrigine and Valproate combination therapy

Outcomes

Primary Outcome Measures

Retention Rate After 52 Weeks Maintenance Period

* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.

Secondary Outcome Measures

Seizure Free Rate for 24 Weeks at Initial Target Dose

Seizure Free Rate for 52 Weeks at Initial Target Dose

Full Information

NCT ID

NCT00807989

First Posted

November 28, 2008

Last Updated

June 29, 2015

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT00807989

Brief Title

The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy

Official Title

An Open Label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies (Phase Ⅳ)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce Lamotrigine metabolism.

Detailed Description

An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Carbamazepine

Arm Type

Active Comparator

Arm Description

Carbamazepine

Arm Title

Lamotrigine/Valproate

Arm Type

Experimental

Arm Description

Lamotrigine and Valproate combination therapy

Intervention Type

Drug

Intervention Name(s)

Carbamazepine

Intervention Type

Drug

Intervention Name(s)

Lamotrigine/Valproate

Primary Outcome Measure Information:

Title

Retention Rate After 52 Weeks Maintenance Period

Description

* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Seizure Free Rate for 24 Weeks at Initial Target Dose

Time Frame

24 weeks

Title

Seizure Free Rate for 52 Weeks at Initial Target Dose

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥16yr old Who are diagnosed as epilepsy definitely Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months Who need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2weeks) Who is not pregnant Who can report seizure diary by him/herself or caregiver Who agree to this trial and provide informed consent. Type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial motor seizures; Exclusion Criteria: Who has progressive CNS disease. Has serious systemic or psychiatric disease Who is not suitable by investigator(uncooperative) Who can not fill up diary check card Is pregnant, breastfeeding, or planning to become pregnant Exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other substance abusers, mental retardation etc. Who cancels to agree to this trial and provide informed consent. ALT, AST, bilirubin and BUN/Cr levels are more than twice normal range of them WBC value is 2000 and less, Hb value is 9.0 and less, platelet count is 100,000 and less in CBC Who took investigation products before participating this study

Overall Study Officials: