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

Epilepsy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807989
• Other study ID #: 109887
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2008
• Last updated: June 29, 2015
• Start date: March 2008
• Est. completion date: May 2012

Study information

• Verified date: June 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

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:
• Carbamazepine

• Lamotrigine/Valproate

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	52 weeks	No
Secondary	Seizure Free Rate for 24 Weeks at Initial Target Dose		24 weeks	No
Secondary	Seizure Free Rate for 52 Weeks at Initial Target Dose		52 weeks	No