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

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)

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Carbamazepine; Drug: Lamotrigine/Valproate

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

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Yonsei medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Carbamazepine	Drug: Carbamazepine
Experimental: Lamotrigine/Valproate; Lamotrigine and Valproate combination therapy	Drug: Lamotrigine/Valproate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Seizure Free Rate for 24 Weeks at Initial Target Dose	24 weeks
Seizure Free Rate for 52 Weeks at Initial Target Dose	52 weeks

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Byung-In Lee, Yonsei Univ.; Principal Investigator: Kyoung Heo, Yonsei Univ.; Principal Investigator: Sang-Kun Lee, Seoul National Univ.; Principal Investigator: Sang-Ahm Lee, Ulsan Univ.; Principal Investigator: Dong-Jin Shin, Gacheon Univ.; Principal Investigator: Hong-Ki Song, Hallym Univ.; Principal Investigator: Young-In Kim, Catholic Univ.; Principal Investigator: Se-Jin Lee, Youngnam Univ.; Principal Investigator: Sang-Ho Kim, Donga Univ.; Principal Investigator: Myung-Gyu Kim, Cheonnam Univ.; Principal Investigator: Yo-Sik Kim, Wonkwang Univ.; Principal Investigator: Sang-Do Lee, Dongsan Hosp.; Principal Investigator: Sung-Eun Kim, Pusan-Bak Hosp.; Principal Investigator: Sung-Pa Park, Kyungbuk Univ.; Principal Investigator: Joo-Yong Kim, Hanrim Univ.; Principal Investigator: Ok-Jun Kim, Bundang Cha; Principal Investigator: Soon-Ki Noh, Bong-Sang Hosp.; Principal Investigator: Hyang-Woon Lee, I-wha Univ.; Principal Investigator: Jae-Moon Kim, Chungnam Univ.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 28, 2008
• First Submitted That Met QC Criteria: December 12, 2008
• First Posted (Estimate): December 15, 2008

Study Record Updates

• Last Update Posted (Estimate): July 27, 2015
• Last Update Submitted That Met QC Criteria: June 29, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; GABA Agents; Anticonvulsants; Sodium Channel Blockers; Antimanic Agents; Cytochrome P-450 Enzyme Inducers; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Cytochrome P-450 CYP3A Inducers; Lamotrigine; Valproic Acid; Carbamazepine
• Other Study ID Numbers: 109887