Trial · NCT00292461

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

NCT00292461, Phase 3, Completed, Eisai Inc.; results first posted 2011-08-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT00292461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00292461

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT00292461
Status: Completed
Phases: Phase 3
Enrollment: 64 participants, actual
Lead sponsor: Eisai Inc.
Conditions: Epilepsy
Interventions: Zonisamide, Lamotrigine
First posted: 2006-02-16
Last updated: 2013-05-20
Results first posted: 2011-08-15

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline	Baseline and 16 weeks	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
Secondary	Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Baseline and 16 weeks
Secondary	Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period	Baseline and 16 weeks
Secondary	Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.	Baseline and 16 weeks

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline	Baseline and 16 weeks	ITT (intent-to-treat)	percent change	MEDIAN
SECONDARY	Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Baseline and 16 weeks		participants	NUMBER
SECONDARY	Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period	Baseline and 16 weeks		participants	NUMBER
SECONDARY	Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.	Baseline and 16 weeks		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline	Zonegran		-32.7	Full Range -100 to 180.0	percent change
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline	Lamotrigine		-35.6	Full Range -100 to 444.4	percent change
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Zonegran	Greatly improved	5		participants
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Lamotrigine	Greatly improved	4		participants
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Zonegran	Somewhat improved	9		participants
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Lamotrigine	Somewhat improved	15		participants
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Zonegran	No change	10		participants
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Lamotrigine	No change	5		participants
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Zonegran	Somewhat worsened	0		participants
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Lamotrigine	Somewhat worsened	0		participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Zonegran	34
Overall Study	STARTED	Lamotrigine	30
Overall Study	COMPLETED	Zonegran	24
Overall Study	COMPLETED	Lamotrigine	24
Overall Study	NOT COMPLETED	Zonegran	10
Overall Study	NOT COMPLETED	Lamotrigine	6

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Disturbance in attention	Nervous system disorders	Zonegran	1	34
other	Disturbance in attention	Nervous system disorders	Lamotrigine	0	30
other	dizziness	Nervous system disorders	Zonegran	2	34
other	dizziness	Nervous system disorders	Lamotrigine	2	30
other	Gait disturbance	Nervous system disorders	Zonegran	0	34
other	Gait disturbance	Nervous system disorders	Lamotrigine	1	30
other	insomnia	Nervous system disorders	Zonegran	0	34
other	insomnia	Nervous system disorders	Lamotrigine	2	30
other	nystagmus	Nervous system disorders	Zonegran	0	34
other	nystagmus	Nervous system disorders	Lamotrigine	1	30

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zonegran
Total, all-cause mortality	Lamotrigine
Total, other adverse events	Zonegran	20	34
Total, other adverse events	Lamotrigine	20	30
Total, serious adverse events	Zonegran	0	34
Total, serious adverse events	Lamotrigine	1	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Zonegran vs Lamotrigine: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00292461

GET https://conductscience.org/api/trials/v1/NCT00292461/results?page=2

API reference For AI assistants