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Trial record 4 of 40 for:    CARBAMAZEPINE AND Valproic Acid

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

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ClinicalTrials.gov Identifier: NCT00807989
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : May 29, 2015
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: Carbamazepine
Drug: Lamotrigine/Valproate
Enrollment 207
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carbamazepine Lamotrigine/Valproate
Hide Arm/Group Description Carbamazepine 100mg/day for the first two weeks. At next two weeks, dose of Carbamazepine was increased to 200mg/day in two divided doses

Lamotrigine and Valproate combination therapy

Lamotrigine 25mg/day for the first two weeks. At next two weeks, LTG 50 mg once a day

Period Title: Overall Study
Started 107 100
Completed 104 98
Not Completed 3 2
Arm/Group Title Carbamazepine Lamotrigine/Valproate Total
Hide Arm/Group Description

Carbamazepine

Carbamazepine

Lamotrigine and Valproate combination therapy

Lamotrigine/Valproate

Total of all reporting groups
Overall Number of Baseline Participants 104 98 202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 104 participants 98 participants 202 participants
33.2  (14.6) 36.5  (13.7) 34.8  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 98 participants 202 participants
Female
51
  49.0%
48
  49.0%
99
  49.0%
Male
53
  51.0%
50
  51.0%
103
  51.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 104 participants 98 participants 202 participants
104 98 202
1.Primary Outcome
Title Retention Rate After 52 Weeks Maintenance Period
Hide Description * Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbamazepine Lamotrigine/Valproate
Hide Arm/Group Description:

Carbamazepine

Carbamazepine

Lamotrigine and Valproate combination therapy

Lamotrigine/Valproate

Overall Number of Participants Analyzed 104 98
Measure Type: Number
Unit of Measure: participants
104 98
2.Secondary Outcome
Title Seizure Free Rate for 24 Weeks at Initial Target Dose
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbamazepine Lamotrigine/Valproate
Hide Arm/Group Description:

Carbamazepine

Carbamazepine

Lamotrigine and Valproate combination therapy

Lamotrigine/Valproate

Overall Number of Participants Analyzed 90 78
Measure Type: Number
Unit of Measure: participants
51 59
3.Secondary Outcome
Title Seizure Free Rate for 52 Weeks at Initial Target Dose
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbamazepine Lamotrigine/Valproate
Hide Arm/Group Description:

Carbamazepine

Carbamazepine

Lamotrigine and Valproate combination therapy

Lamotrigine/Valproate

Overall Number of Participants Analyzed 90 78
Measure Type: Number
Unit of Measure: participants
43 50
Time Frame 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carbamazepine Lamotrigine/Valproate
Hide Arm/Group Description

Carbamazepine

Carbamazepine

Lamotrigine and Valproate combination therapy

Lamotrigine/Valproate

All-Cause Mortality
Carbamazepine Lamotrigine/Valproate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Carbamazepine Lamotrigine/Valproate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/104 (8.65%)      0/98 (0.00%)    
Cardiac disorders     
Ventricular tachycardia   1/104 (0.96%)  1 0/98 (0.00%)  0
Infections and infestations     
Meningoencephalitis herpetic   1/104 (0.96%)  1 0/98 (0.00%)  0
Pneumonia   1/104 (0.96%)  1 0/98 (0.00%)  0
Injury, poisoning and procedural complications     
Joint dislocation   1/104 (0.96%)  1 0/98 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Facet joint syndrome   1/104 (0.96%)  1 0/98 (0.00%)  0
Nervous system disorders     
Alcoholic seizure   1/104 (0.96%)  1 0/98 (0.00%)  0
Atonic seizures   1/104 (0.96%)  1 0/98 (0.00%)  0
Psychiatric disorders     
Abnormal behaviour   1/104 (0.96%)  1 0/98 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin rash   1/104 (0.96%)  1 0/98 (0.00%)  0
Surgical and medical procedures     
Hospitalisation   1/104 (0.96%)  1 0/98 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carbamazepine Lamotrigine/Valproate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/104 (57.69%)      59/98 (60.20%)    
Gastrointestinal disorders     
Dyspepsia   7/104 (6.73%)  8 5/98 (5.10%)  7
General disorders     
Fatigue   10/104 (9.62%)  10 4/98 (4.08%)  5
Infections and infestations     
Nasopharyngitis   7/104 (6.73%)  9 10/98 (10.20%)  26
Metabolism and nutrition disorders     
Weight gain   9/104 (8.65%)  9 6/98 (6.12%)  6
Nervous system disorders     
Headache   26/104 (25.00%)  29 26/98 (26.53%)  52
Dizziness   18/104 (17.31%)  23 17/98 (17.35%)  18
Somnolence   14/104 (13.46%)  15 12/98 (12.24%)  12
Memory impairment   10/104 (9.62%)  14 5/98 (5.10%)  5
Tremor   2/104 (1.92%)  2 11/98 (11.22%)  11
Skin and subcutaneous tissue disorders     
Skin rash   7/104 (6.73%)  7 6/98 (6.12%)  6
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Yoon
Organization: Yonsei University Severance Hospital
EMail: BILEE@yuhs.ac
Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT00807989     History of Changes
Other Study ID Numbers: 109887
First Submitted: November 28, 2008
First Posted: December 15, 2008
Results First Submitted: January 20, 2014
Results First Posted: May 29, 2015
Last Update Posted: July 27, 2015