Trial Outcomes & Findings for Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation (NCT NCT01127256)
NCT ID: NCT01127256
Last Updated: 2022-01-04
Results Overview
The percentage of participants who had no seizure during the trial.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
24 weeks
Results posted on
2022-01-04
Participant Flow
This study was recruited at 12 centers in Korea during the period of May 2006 to May 2009.
Participant milestones
| Measure |
Zonisamide
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
|
Carbamazepine
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
104
|
|
Overall Study
COMPLETED
|
57
|
65
|
|
Overall Study
NOT COMPLETED
|
39
|
39
|
Reasons for withdrawal
| Measure |
Zonisamide
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
|
Carbamazepine
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
13
|
|
Overall Study
Lack of Efficacy
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
16
|
17
|
|
Overall Study
Withdrawal by Subject
|
5
|
9
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Baseline characteristics by cohort
| Measure |
Zonisamide
n=96 Participants
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
|
Carbamazepine
n=104 Participants
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
35.7 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
96 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThe percentage of participants who had no seizure during the trial.
Outcome measures
| Measure |
Zonisamide
n=96 Participants
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
|
Carbamazepine
n=104 Participants
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
|
|---|---|---|
|
The Percentage of Participants With Seizure Free Rate
|
73.7 percentage of participants
|
83.1 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeksThe percentage of participants who completed the trial.
Outcome measures
| Measure |
Zonisamide
n=96 Participants
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
|
Carbamazepine
n=104 Participants
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
|
|---|---|---|
|
The Percentage of Participants With Retention Rate
|
59.4 percentage of participants
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeksQuality 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.
Outcome measures
| Measure |
Zonisamide
n=96 Participants
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
|
Carbamazepine
n=104 Participants
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
|
|---|---|---|
|
Quality of Life in Epilepsy (QoL-QOLIE31)
Pre-QOLIE 31
|
60.72 Units On a Scale
Standard Deviation 14.69
|
61.96 Units On a Scale
Standard Deviation 16.67
|
|
Quality of Life in Epilepsy (QoL-QOLIE31)
Post-QOLIE 31
|
67.27 Units On a Scale
Standard Deviation 16.34
|
69.51 Units On a Scale
Standard Deviation 17.61
|
Adverse Events
Zonisamide
Serious events: 5 serious events
Other events: 74 other events
Deaths: 0 deaths
Carbamazepine
Serious events: 9 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zonisamide
n=96 participants at risk
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
|
Carbamazepine
n=104 participants at risk
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
|
|---|---|---|
|
Psychiatric disorders
Worsening Insomnia
|
1.0%
1/96 • Number of events 1
|
0.00%
0/104
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
1.0%
1/96 • Number of events 1
|
0.00%
0/104
|
|
Psychiatric disorders
Depressive Mood
|
1.0%
1/96 • Number of events 1
|
0.00%
0/104
|
|
General disorders
Right Shoulder Injury
|
1.0%
1/96 • Number of events 1
|
0.00%
0/104
|
|
Psychiatric disorders
Visual Hallucination
|
1.0%
1/96 • Number of events 1
|
0.00%
0/104
|
|
General disorders
Cervical Sprain
|
1.0%
1/96 • Number of events 1
|
0.00%
0/104
|
|
Psychiatric disorders
Memory And Judgement Disturbance
|
1.0%
1/96 • Number of events 1
|
0.00%
0/104
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/96
|
0.96%
1/104 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/96
|
3.8%
4/104 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/96
|
0.96%
1/104 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/96
|
0.96%
1/104 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/96
|
0.96%
1/104 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine Fibroid
|
0.00%
0/96
|
0.96%
1/104 • Number of events 1
|
|
Investigations
Sgpt Increased
|
0.00%
0/96
|
0.96%
1/104 • Number of events 1
|
|
Investigations
Sgot Increased
|
0.00%
0/96
|
0.96%
1/104 • Number of events 1
|
|
Psychiatric disorders
Mental Torpor
|
0.00%
0/96
|
0.96%
1/104 • Number of events 1
|
Other adverse events
| Measure |
Zonisamide
n=96 participants at risk
Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
|
Carbamazepine
n=104 participants at risk
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
29.2%
28/96 • Number of events 30
|
22.1%
23/104 • Number of events 24
|
|
Psychiatric disorders
Drowsiness
|
26.0%
25/96 • Number of events 25
|
23.1%
24/104 • Number of events 25
|
|
Gastrointestinal disorders
Anorexia
|
20.8%
20/96 • Number of events 21
|
4.8%
5/104 • Number of events 5
|
|
Investigations
Weight Decrease
|
16.7%
16/96 • Number of events 17
|
1.9%
2/104 • Number of events 2
|
|
Nervous system disorders
Headache
|
14.6%
14/96 • Number of events 14
|
13.5%
14/104 • Number of events 14
|
|
Gastrointestinal disorders
Nausea
|
11.5%
11/96 • Number of events 11
|
11.5%
12/104 • Number of events 14
|
|
Psychiatric disorders
Memory Impairment
|
9.4%
9/96 • Number of events 9
|
4.8%
5/104 • Number of events 5
|
|
Psychiatric disorders
Mental Torpor
|
7.3%
7/96 • Number of events 7
|
11.5%
12/104 • Number of events 12
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
7.3%
7/96 • Number of events 7
|
1.9%
2/104 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
7/96 • Number of events 7
|
3.8%
4/104 • Number of events 5
|
|
Psychiatric disorders
Sleep Disorder
|
6.2%
6/96 • Number of events 6
|
3.8%
4/104 • Number of events 4
|
|
General disorders
Fatigue
|
7.3%
7/96 • Number of events 7
|
5.8%
6/104 • Number of events 6
|
|
General disorders
Pyrexia
|
6.2%
6/96 • Number of events 6
|
7.7%
8/104 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
6/96 • Number of events 6
|
3.8%
4/104 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
5/96 • Number of events 6
|
1.9%
2/104 • Number of events 2
|
|
Psychiatric disorders
Depression
|
4.2%
4/96 • Number of events 4
|
1.9%
2/104 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/96
|
4.8%
5/104 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/96 • Number of events 1
|
6.7%
7/104 • Number of events 7
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/96 • Number of events 1
|
5.8%
6/104 • Number of events 7
|
Additional Information
Jihee Mun, Pharmacist, Medical Department manager
Eisai Korea Inc.
Phone: +82-2-3451-5531
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place