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

NCT00807989 | Completed Phase 4 Results

• 1 other identifier: 109887
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Seizure Free Rate for 24 Weeks at Initial Target Dose

  24 weeks

• Seizure Free Rate for 52 Weeks at Initial Target Dose

  52 weeks

Study Arms (2)

Carbamazepine

ACTIVE COMPARATOR

Carbamazepine

Drug: Carbamazepine

Lamotrigine/Valproate

EXPERIMENTAL

Lamotrigine and Valproate combination therapy

Drug: Lamotrigine/Valproate

Interventions

Carbamazepine DRUG

Carbamazepine

Lamotrigine/Valproate DRUG

Lamotrigine/Valproate

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Medical Center

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Carbamazepine; Lamotrigine; Valproic Acid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triazines; Heterocyclic Compounds, 1-Ring; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Results Point of Contact

• Title: Dr. Yoon
• Organization: Yonsei University Severance Hospital

BILEE@yuhs.ac

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2008
• First Posted: December 15, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 27, 2015
• Results First Posted: May 29, 2015

Record last verified: 2015-06

Locations

KR (1)