Trial Outcomes & Findings for Low and High Dose Zonisamide in Children as Monotherapy (NCT NCT01127165)
NCT ID: NCT01127165
Last Updated: 2012-07-31
Results Overview
The percentage of participants who showed no seizure during the maintenance phase.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
125 participants
Primary outcome timeframe
24 weeks
Results posted on
2012-07-31
Participant Flow
This study was recruited at 11 centers in Korea during the period of March 2006 to July 2009.
Participant milestones
| Measure |
Zonisamide Low Dose Group
Initial dose was 2 mg/kg/day, increased after 1\~2 weeks to 3\~4 mg/kg/day.
|
Zonisamide High Dose Group
Initial dose was 2 mg/kg/day, increased after 2\~4 weeks to 6\~8 mg/kg/day.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
60
|
|
Overall Study
COMPLETED
|
49
|
41
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
| Measure |
Zonisamide Low Dose Group
Initial dose was 2 mg/kg/day, increased after 1\~2 weeks to 3\~4 mg/kg/day.
|
Zonisamide High Dose Group
Initial dose was 2 mg/kg/day, increased after 2\~4 weeks to 6\~8 mg/kg/day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
10
|
8
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Low and High Dose Zonisamide in Children as Monotherapy
Baseline characteristics by cohort
| Measure |
Zonisamide Low Dose Group
n=65 Participants
Initial dose was 2 mg/kg/day, increased after 1\~2 weeks to 3\~4 mg/kg/day.
|
Zonisamide High Dose Group
n=60 Participants
Initial dose was 2 mg/kg/day, increased after 2\~4 weeks to 6\~8 mg/kg/day.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
8.3 years
STANDARD_DEVIATION 3.0 • n=93 Participants
|
7.8 years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
8.1 years
STANDARD_DEVIATION 3.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
65 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
125 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThe percentage of participants who showed no seizure during the maintenance phase.
Outcome measures
| Measure |
Zonisamide Low Dose Group
n=49 Participants
Initial dose was 2 mg/kg/day, increased after 1\~2 weeks to 3\~4 mg/kg/day.
|
Zonisamide High Dose Group
n=41 Participants
Initial dose was 2 mg/kg/day, increased after 2\~4 weeks to 6\~8 mg/kg/day.
|
|---|---|---|
|
Percentage of Participants Who Were Assessed As Seizure Free
|
63.1 percentage of participants
|
57.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksCognitive assessment was performed using K-WISC-III. The total score of K-WISC-III is calculated as Full Scale IQ which ranges from 31 (worst) to 151(best). Higher scores indicate greater intelligence, lower scores indicate less intelligence. Thus a positive change indicated an improvement.
Outcome measures
| Measure |
Zonisamide Low Dose Group
n=23 Participants
Initial dose was 2 mg/kg/day, increased after 1\~2 weeks to 3\~4 mg/kg/day.
|
Zonisamide High Dose Group
n=28 Participants
Initial dose was 2 mg/kg/day, increased after 2\~4 weeks to 6\~8 mg/kg/day.
|
|---|---|---|
|
Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)
|
-1.3913 Scores on a Scale
Standard Deviation 9.13
|
0.1071 Scores on a Scale
Standard Deviation 10.77
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksThe difference of K-CBCL between before and after the administration. K-CBCL is the Korean version of CBCL which is a standardized form that parents fill out to describe their children's behavioral and emotional problems. The total score ranges 0- 234, with higher scores indicating worse behavioral and emotional problems.
Outcome measures
| Measure |
Zonisamide Low Dose Group
n=27 Participants
Initial dose was 2 mg/kg/day, increased after 1\~2 weeks to 3\~4 mg/kg/day.
|
Zonisamide High Dose Group
n=36 Participants
Initial dose was 2 mg/kg/day, increased after 2\~4 weeks to 6\~8 mg/kg/day.
|
|---|---|---|
|
Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)
|
-5.259 Scores on a Scale
Standard Deviation 7.31
|
-1.611 Scores on a Scale
Standard Deviation 5.83
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksThe difference of K-QOLCE between before and after the administration. K-QOLCE is Korean version of the Quality of Life in Childhood Epilepsy Questionnaire. The calculated total score ranges 0-100, with higher scores indicating higher quality of life.
Outcome measures
| Measure |
Zonisamide Low Dose Group
n=23 Participants
Initial dose was 2 mg/kg/day, increased after 1\~2 weeks to 3\~4 mg/kg/day.
|
Zonisamide High Dose Group
n=28 Participants
Initial dose was 2 mg/kg/day, increased after 2\~4 weeks to 6\~8 mg/kg/day.
|
|---|---|---|
|
Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)
|
4.7931 Scores on a Scale
Standard Deviation 0.167
|
1.2286 Scores on a Scale
Standard Deviation 0.776
|
Adverse Events
Zonisamide Low Dose Group
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Zonisamide High Dose Group
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zonisamide Low Dose Group
n=65 participants at risk
Initial dose was 2 mg/kg/day, increased after 1\~2 weeks to 3\~4 mg/kg/day.
|
Zonisamide High Dose Group
n=60 participants at risk
Initial dose was 2 mg/kg/day, increased after 2\~4 weeks to 6\~8 mg/kg/day.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/65
|
1.7%
1/60
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/65
|
1.7%
1/60
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.5%
1/65
|
1.7%
1/60
|
|
Gastrointestinal disorders
Acute gastroenteritis
|
1.5%
1/65
|
0.00%
0/60
|
Other adverse events
| Measure |
Zonisamide Low Dose Group
n=65 participants at risk
Initial dose was 2 mg/kg/day, increased after 1\~2 weeks to 3\~4 mg/kg/day.
|
Zonisamide High Dose Group
n=60 participants at risk
Initial dose was 2 mg/kg/day, increased after 2\~4 weeks to 6\~8 mg/kg/day.
|
|---|---|---|
|
Psychiatric disorders
Somnolence
|
3.1%
2/65
|
5.0%
3/60
|
|
Nervous system disorders
Dizziness
|
1.5%
1/65
|
5.0%
3/60
|
|
Gastrointestinal disorders
Anorexia
|
4.6%
3/65
|
1.7%
1/60
|
|
General disorders
Fatigue
|
3.1%
2/65
|
1.7%
1/60
|
|
Renal and urinary disorders
Micturition Disorder
|
0.00%
0/65
|
5.0%
3/60
|
|
Nervous system disorders
Headache
|
1.5%
1/65
|
1.7%
1/60
|
|
General disorders
Weight Decrease
|
3.1%
2/65
|
0.00%
0/60
|
|
Psychiatric disorders
Memory Impairment
|
1.5%
1/65
|
1.7%
1/60
|
|
Nervous system disorders
Dysaesthesia
|
1.5%
1/65
|
0.00%
0/60
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/65
|
1.7%
1/60
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/65
|
1.7%
1/60
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/65
|
1.7%
1/60
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/65
|
1.7%
1/60
|
|
Skin and subcutaneous tissue disorders
Sweating Decreased
|
0.00%
0/65
|
1.7%
1/60
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/65
|
0.00%
0/60
|
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