Trial Outcomes & Findings for A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures (NCT NCT00292461)
NCT ID: NCT00292461
Last Updated: 2013-05-20
Results Overview
Percentage Change of Frequency = (T-B)/B\*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)\* 4 B= The monthly seizure frequence with one month prior to enrollment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
64 participants
Primary outcome timeframe
Baseline and 16 weeks
Results posted on
2013-05-20
Participant Flow
Participant milestones
| Measure |
Zonegran
once or twice daily orally for 16 weeks
|
Lamotrigine
once daily orally for 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
30
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
Zonegran
once or twice daily orally for 16 weeks
|
Lamotrigine
once daily orally for 16 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures
Baseline characteristics by cohort
| Measure |
Zonegran
n=34 Participants
once or twice daily orally for 16 weeks
|
Lamotrigine
n=30 Participants
once daily orally for 16 weeks
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
38.3 years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
35.0 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
36.8 years
STANDARD_DEVIATION 10.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
31 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
|
34 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
64 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
|
|
Region of Enrollment
Taiwan
|
34 participants
n=93 Participants
|
30 participants
n=4 Participants
|
64 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: ITT (intent-to-treat)
Percentage Change of Frequency = (T-B)/B\*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)\* 4 B= The monthly seizure frequence with one month prior to enrollment
Outcome measures
| Measure |
Zonegran
n=24 Participants
once or twice daily orally for 16 weeks
|
Lamotrigine
n=24 Participants
once daily orally for 16 weeks
|
|---|---|---|
|
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
|
-32.7 percent change
Interval -100.0 to 180.0
|
-35.6 percent change
Interval -100.0 to 444.4
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksOutcome measures
| Measure |
Zonegran
n=24 Participants
once or twice daily orally for 16 weeks
|
Lamotrigine
n=24 Participants
once daily orally for 16 weeks
|
|---|---|---|
|
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
Greatly improved
|
5 participants
|
4 participants
|
|
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
Somewhat improved
|
9 participants
|
15 participants
|
|
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
No change
|
10 participants
|
5 participants
|
|
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
Somewhat worsened
|
0 participants
|
0 participants
|
|
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
Greatly worsened
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksOutcome measures
| Measure |
Zonegran
n=24 Participants
once or twice daily orally for 16 weeks
|
Lamotrigine
n=24 Participants
once daily orally for 16 weeks
|
|---|---|---|
|
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
Greatly improved
|
3 participants
|
8 participants
|
|
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
Somewhat improved
|
14 participants
|
12 participants
|
|
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
No change
|
4 participants
|
4 participants
|
|
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
Somewhat worsened
|
3 participants
|
0 participants
|
|
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
Greatly worsened
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksOutcome measures
| Measure |
Zonegran
n=24 Participants
once or twice daily orally for 16 weeks
|
Lamotrigine
n=24 Participants
once daily orally for 16 weeks
|
|---|---|---|
|
Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.
|
45.8 percentage of participants
|
45.8 percentage of participants
|
Adverse Events
Zonegran
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Lamotrigine
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zonegran
n=34 participants at risk
once or twice daily orally for 16 weeks
|
Lamotrigine
n=30 participants at risk
once daily orally for 16 weeks
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Lumber contusion
|
0.00%
0/34
|
3.3%
1/30
|
|
Nervous system disorders
nystagmus
|
0.00%
0/34
|
3.3%
1/30
|
Other adverse events
| Measure |
Zonegran
n=34 participants at risk
once or twice daily orally for 16 weeks
|
Lamotrigine
n=30 participants at risk
once daily orally for 16 weeks
|
|---|---|---|
|
Nervous system disorders
Disturbance in attention
|
2.9%
1/34
|
0.00%
0/30
|
|
Nervous system disorders
dizziness
|
5.9%
2/34
|
6.7%
2/30
|
|
Nervous system disorders
Gait disturbance
|
0.00%
0/34
|
3.3%
1/30
|
|
Nervous system disorders
insomnia
|
0.00%
0/34
|
6.7%
2/30
|
|
Nervous system disorders
nystagmus
|
0.00%
0/34
|
3.3%
1/30
|
|
Nervous system disorders
somnolence
|
5.9%
2/34
|
6.7%
2/30
|
|
Investigations
White blood cell urine positive
|
2.9%
1/34
|
0.00%
0/30
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
2/34
|
0.00%
0/30
|
|
Investigations
Electrocardiogram abnormal
|
2.9%
1/34
|
0.00%
0/30
|
|
Investigations
Hepatic enzyme abnormal
|
8.8%
3/34
|
0.00%
0/30
|
|
Investigations
Red blood cell urine positive
|
5.9%
2/34
|
0.00%
0/30
|
|
Investigations
Weight decreased
|
2.9%
1/34
|
0.00%
0/30
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/34
|
3.3%
1/30
|
|
Gastrointestinal disorders
nausia
|
0.00%
0/34
|
3.3%
1/30
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/34
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
anorexia
|
2.9%
1/34
|
3.3%
1/30
|
|
General disorders
malaise
|
2.9%
1/34
|
0.00%
0/30
|
|
Blood and lymphatic system disorders
splenomegaly
|
2.9%
1/34
|
0.00%
0/30
|
|
Hepatobiliary disorders
Hepatic function disorders
|
2.9%
1/34
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
contusion
|
0.00%
0/34
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/34
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
rash
|
2.9%
1/34
|
6.7%
2/30
|
|
Eye disorders
diplopia
|
0.00%
0/34
|
10.0%
3/30
|
|
Eye disorders
Vision blurred
|
0.00%
0/34
|
3.3%
1/30
|
Additional Information
Takao Ishii, Asia regulatory affaires
Eisai Co., Ltd.
Phone: 81-3-3817-3914
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place