Trial · NCT00693017

Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy

NCT00693017, Phase 3, Terminated, Eisai Limited; results first posted 2012-09-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy. Trials, record NCT00693017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00693017

On this page

Trial

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

Title: Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy
NCT number: NCT00693017
Status: Terminated
Phases: Phase 3
Enrollment: 10 participants, actual
Lead sponsor: Eisai Limited
Conditions: Epilepsy
Interventions: Zonisamide, Placebo
First posted: 2008-06-06
Last updated: 2015-12-24
Other registries' IDs: eudract:2007-003556-10
Results first posted: 2012-09-12
Limitations and caveats: Due to early termination of the study by the Sponsor. No formal analyses were conducted.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Participants Considered Responders as Assessed During the Maintenance Period	Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)	The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease \>= 50% from baseline in the number of days with myoclonic seizures per 28 days (i.e. 28-day myoclonic seizure frequency in Period from Week 4 to the Week 16 visit compared to Week -8 to randomization at Week 0 \[Screening/ Baseline Period\]). Occurrence of seizures was documented in a seizure diary. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) and reviewed at each following visit. The diary was completed daily. All seizures except myoclonic seizures were counted individually in the the diary. Due to early termination of the study by the Sponsor, no formal analyses were conducted.
Secondary	Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures	Baseline and up to 16 weeks	Percentage Change from Baseline in the monthly number of days with myoclonic seizures was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Considered Responders as Assessed During the Maintenance Period	Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)
SECONDARY	Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures	Baseline and up to 16 weeks

Source ClinicalTrials.gov

Results by group0

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

None in this release.

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Zonisamide	2
Overall Study	STARTED	Placebo	2
Overall Study	COMPLETED	Zonisamide	0
Overall Study	COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Zonisamide	2
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events14

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	Vision blurred	Eye disorders	Zonisamide	1	2
other	Vision blurred	Eye disorders	Placebo	1	2
other	Vomiting	Gastrointestinal disorders	Zonisamide	1	2
other	Vomiting	Gastrointestinal disorders	Placebo	0	2
other	Dizziness	Nervous system disorders	Zonisamide	1	2
other	Dizziness	Nervous system disorders	Placebo	0	2
other	Headache	Nervous system disorders	Zonisamide	0	2
other	Headache	Nervous system disorders	Placebo	1	2
other	Somnolence	Nervous system disorders	Zonisamide	1	2
other	Somnolence	Nervous system disorders	Placebo	0	2

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zonisamide
Total, all-cause mortality	Placebo
Total, other adverse events	Zonisamide	2	2
Total, other adverse events	Placebo	2	2
Total, serious adverse events	Zonisamide	0	2
Total, serious adverse events	Placebo	1	2

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
Zonisamide vs Placebo: 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/NCT00693017

GET https://conductscience.org/api/trials/v1/NCT00693017/registered

API reference For AI assistants