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Trial record 38 of 89 for:    CARBAMAZEPINE AND Psychotropic

Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation

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ClinicalTrials.gov Identifier: NCT01127256
Recruitment Status : Completed
First Posted : May 20, 2010
Results First Posted : July 26, 2012
Last Update Posted : July 26, 2012
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: zonisamide
Drug: carbamazepine
Enrollment 200
Recruitment Details This study was recruited at 12 centers in Korea during the period of May 2006 to May 2009.
Pre-assignment Details  
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day. Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
Period Title: Overall Study
Started 96 104
Completed 57 65
Not Completed 39 39
Reason Not Completed
Adverse Event             13             13
Lack of Efficacy             4             0
Lost to Follow-up             16             17
Withdrawal by Subject             5             9
Protocol Violation             1             0
Arm/Group Title Zonisamide Carbamazepine Total
Hide Arm/Group Description Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day. Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day. Total of all reporting groups
Overall Number of Baseline Participants 96 104 200
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 104 participants 200 participants
39.8  (15.9) 35.7  (15.1) 37.7  (15.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 104 participants 200 participants
Female
49
  51.0%
53
  51.0%
102
  51.0%
Male
47
  49.0%
51
  49.0%
98
  49.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 104 participants 200 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
96
 100.0%
104
 100.0%
200
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Percentage of Participants With Seizure Free Rate
Hide Description The percentage of participants who had no seizure during the trial.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description:
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
Overall Number of Participants Analyzed 96 104
Measure Type: Number
Unit of Measure: percentage of participants
73.7 83.1
2.Secondary Outcome
Title The Percentage of Participants With Retention Rate
Hide Description The percentage of participants who completed the trial.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description:
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
Overall Number of Participants Analyzed 96 104
Measure Type: Number
Unit of Measure: percentage of participants
59.4 62.5
3.Secondary Outcome
Title Quality of Life in Epilepsy (QoL-QOLIE31)
Hide Description Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description:
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
Overall Number of Participants Analyzed 96 104
Mean (Standard Deviation)
Unit of Measure: Units On a Scale
Pre-QOLIE 31 60.72  (14.69) 61.96  (16.67)
Post-QOLIE 31 67.27  (16.34) 69.51  (17.61)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day. Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
All-Cause Mortality
Zonisamide Carbamazepine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zonisamide Carbamazepine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/96 (5.21%)      9/104 (8.65%)    
Gastrointestinal disorders     
Constipation  0/96 (0.00%)  0 1/104 (0.96%)  1
General disorders     
Right Shoulder Injury  1/96 (1.04%)  1 0/104 (0.00%)  0
Cervical Sprain  1/96 (1.04%)  1 0/104 (0.00%)  0
Investigations     
Sgpt Increased  0/96 (0.00%)  0 1/104 (0.96%)  1
Sgot Increased  0/96 (0.00%)  0 1/104 (0.96%)  1
Metabolism and nutrition disorders     
Diabetic Ketoacidosis  1/96 (1.04%)  1 0/104 (0.00%)  0
Psychiatric disorders     
Worsening Insomnia  1/96 (1.04%)  1 0/104 (0.00%)  0
Depressive Mood  1/96 (1.04%)  1 0/104 (0.00%)  0
Visual Hallucination  1/96 (1.04%)  1 0/104 (0.00%)  0
Memory And Judgement Disturbance  1/96 (1.04%)  1 0/104 (0.00%)  0
Mental Torpor  0/96 (0.00%)  0 1/104 (0.96%)  1
Renal and urinary disorders     
Dysuria  0/96 (0.00%)  0 1/104 (0.96%)  1
Reproductive system and breast disorders     
Uterine Fibroid  0/96 (0.00%)  0 1/104 (0.96%)  1
Skin and subcutaneous tissue disorders     
Pruritus  0/96 (0.00%)  0 1/104 (0.96%)  1
Urticaria  0/96 (0.00%)  0 4/104 (3.85%)  4
Rash  0/96 (0.00%)  0 1/104 (0.96%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Zonisamide Carbamazepine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/96 (77.08%)      70/104 (67.31%)    
Gastrointestinal disorders     
Anorexia  20/96 (20.83%)  21 5/104 (4.81%)  5
Nausea  11/96 (11.46%)  11 12/104 (11.54%)  14
Gastrointestinal Pain  7/96 (7.29%)  7 2/104 (1.92%)  2
Diarrhoea  5/96 (5.21%)  6 2/104 (1.92%)  2
Constipation  1/96 (1.04%)  1 7/104 (6.73%)  7
Dyspepsia  1/96 (1.04%)  1 6/104 (5.77%)  7
General disorders     
Fatigue  7/96 (7.29%)  7 6/104 (5.77%)  6
Pyrexia  6/96 (6.25%)  6 8/104 (7.69%)  9
Investigations     
Weight Decrease  16/96 (16.67%)  17 2/104 (1.92%)  2
Nervous system disorders     
Dizziness  28/96 (29.17%)  30 23/104 (22.12%)  24
Headache  14/96 (14.58%)  14 14/104 (13.46%)  14
Psychiatric disorders     
Drowsiness  25/96 (26.04%)  25 24/104 (23.08%)  25
Memory Impairment  9/96 (9.38%)  9 5/104 (4.81%)  5
Mental Torpor  7/96 (7.29%)  7 12/104 (11.54%)  12
Sleep Disorder  6/96 (6.25%)  6 4/104 (3.85%)  4
Depression  4/96 (4.17%)  4 2/104 (1.92%)  2
Skin and subcutaneous tissue disorders     
Pruritus  7/96 (7.29%)  7 4/104 (3.85%)  5
Rash  6/96 (6.25%)  6 4/104 (3.85%)  4
Urticaria  0/96 (0.00%)  0 5/104 (4.81%)  5
Early termination leading to small numbers of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Jihee Mun, Pharmacist, Medical Department manager
Organization: Eisai Korea Inc.
Phone: +82-2-3451-5531
EMail: jihee_mun@eisaikorea.com
Layout table for additonal information
Responsible Party: Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier: NCT01127256     History of Changes
Other Study ID Numbers: E2090-S082-405
First Submitted: May 19, 2010
First Posted: May 20, 2010
Results First Submitted: August 2, 2010
Results First Posted: July 26, 2012
Last Update Posted: July 26, 2012