Trial · NCT00334958

Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures

NCT00334958, Phase 3, Completed, Eisai Inc.; results first posted 2013-02-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures. Trials, record NCT00334958. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00334958

On this page

Trial

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

Title: Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
NCT number: NCT00334958
Status: Completed
Phases: Phase 3
Enrollment: 356 participants, actual
Lead sponsor: Eisai Inc.
Conditions: Epilepsy
Interventions: Placebo, Rufinamide
First posted: 2006-06-08
Last updated: 2021-06-14
Other registries' IDs: eudract:2016-004944-12
Results first posted: 2013-02-05

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase	Baseline, Days 13 to 96	Seizure data was collected via patient diary, which was used to record daily seizure count and type. Intent-to-treat (ITT) population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.
Secondary	Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase	Baseline, Days 13 to 96	Seizure data was collected via patient diary, which was used to record daily seizure count and type.
Secondary	Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase	Days 13 to 96	Total partial seizure frequencies per 28 days during the double-blind Maintenance and Baseline Phases were transformed using logarithms to the base 10 (log10), because it was expected from previous studies that the results would not be normally distributed.
Secondary	Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase	Baseline, Days 13 to 96	RRATIO= 100\*(T-B)/(T+B) where T= total seizure frequency per 28 days during the Maintenance Phase, and B=total seizure frequency per 28 days during the Baseline Phase.

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	Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase	Baseline, Days 13 to 96	Intent-to-treat (ITT) population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.	Percentage change	MEDIAN
SECONDARY	Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase	Baseline, Days 13 to 96	ITT population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.	Percentage of Participants	NUMBER
SECONDARY	Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase	Days 13 to 96	ITT population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.	Seizures per 28-days (log-transformed)	MEAN
SECONDARY	Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase	Baseline, Days 13 to 96	ITT population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.	RRATIO	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase	Rufinamide	-23.25	Full Range -100.0 to 725.6	Percentage change
Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase	Placebo	-9.80	Full Range -100.0 to 864.3	Percentage change
Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase	Rufinamide	32.5		Percentage of Participants
Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase	Placebo	14.3		Percentage of Participants
Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase	Rufinamide	0.98	Standard Deviation 0.675	Seizures per 28-days (log-transformed)
Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase	Placebo	1.13	Standard Deviation 0.520	Seizures per 28-days (log-transformed)
Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase	Rufinamide	-18.76	Standard Deviation 37.841	RRATIO
Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase	Placebo	-6.90	Standard Deviation 24.869	RRATIO

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Rufinamide	176
Overall Study	STARTED	Placebo	180
Overall Study	COMPLETED	Rufinamide	139
Overall Study	COMPLETED	Placebo	156
Overall Study	NOT COMPLETED	Rufinamide	37
Overall Study	NOT COMPLETED	Placebo	24

Source ClinicalTrials.gov

Adverse events48

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	Diplopia	Eye disorders	Rufinamide	14	176
other	Diplopia	Eye disorders	Placebo	2	180
other	Nausea	Gastrointestinal disorders	Rufinamide	22	176
other	Nausea	Gastrointestinal disorders	Placebo	9	180
other	Vomiting	Gastrointestinal disorders	Rufinamide	13	176
other	Vomiting	Gastrointestinal disorders	Placebo	9	180
other	Fatigue	General disorders	Rufinamide	27	176
other	Fatigue	General disorders	Placebo	18	180
other	Upper respiratory tract infection	Infections and infestations	Rufinamide	6	176
other	Upper respiratory tract infection	Infections and infestations	Placebo	15	180

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rufinamide	0	176
Total, all-cause mortality	Placebo	0	180
Total, other adverse events	Rufinamide	101	176
Total, other adverse events	Placebo	66	180
Total, serious adverse events	Rufinamide	6	176
Total, serious adverse events	Placebo	7	180

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33179247	DERIVED

Source PubMed

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 comparisons2

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

Comparison	Source
Rufinamide vs Placebo: deaths from any cause	Trial comparisons
Rufinamide vs Placebo: serious adverse events	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/NCT00334958

GET https://conductscience.org/api/trials/v1/NCT00334958/events?page=2

API reference For AI assistants