Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures

This study has been terminated.

(Sponsor's decision)

Sponsor:

Information provided by (Responsible Party):

Eisai Inc. ( Eisai Limited )

ClinicalTrials.gov Identifier:

NCT00692003

First received: June 3, 2008

Last updated: September 11, 2012

Last verified: September 2012

History of Changes

Results First Received: August 13, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Epilepsy
Interventions:	Drug: Zonisamide Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was recruited at 6 centers (3 in Romania and 1 in Australia, Hungary, and Lithuania) during the period of 01 August 2008 to 28 January 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty-one subjects were screened and 14 participants did not continue the study after screening. Seven participants entered the study but 1 participant did not receive any treatment. Consequently, 6 participants were enrolled and treated during the study. None of the 6 subjects completed treatment & all discontinued due to the Sponsor's decision.

Reporting Groups

	Description
Zonisamide	25-400 mg capsules orally once daily in the evening. Maximum study duration of 28 weeks comprising: Baseline Period (Week-8/-4 to Week 0) no treatment Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events) Down Titration Period (4 weeks)
Placebo	25-400 mg Zonisamide Placebo capsules orally once daily in the evening. Maximum study duration of 28 weeks comprising: Baseline Period (Week-8/-4 to Week 0) no treatment Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events) Down Titration Period (4 weeks)

Description

Zonisamide

25-400 mg capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;

>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

Placebo

25-400 mg Zonisamide Placebo capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo;

>= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

Participant Flow: Overall Study

	Zonisamide	Placebo
STARTED	5	1
COMPLETED	0	0
NOT COMPLETED	5	1
Sponsor Decision	5	1

Baseline Characteristics

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Reporting Groups

	Description
Zonisamide	25-400 mg capsules orally once daily in the evening. Maximum study duration of 28 weeks comprising: Baseline Period (Week-8/-4 to Week 0) no treatment Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events) Down Titration Period (4 weeks)
Placebo	25-400 mg Zonisamide Placebo capsules orally once daily in the evening. Maximum study duration of 28 weeks comprising: Baseline Period (Week-8/-4 to Week 0) no treatment Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events) Down Titration Period (4 weeks)
Total	Total of all reporting groups

Description

Zonisamide

25-400 mg capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;

>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

Placebo

25-400 mg Zonisamide Placebo capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

Total

Total of all reporting groups

Baseline Measures

	Zonisamide	Placebo	Total
Number of Participants [units: participants]	5	1	6
Age [units: years] Mean ± Standard Deviation	38.4 ± -18.66	27.0	36.5 ± 17.33
Gender [units: participants]
Female	3	0	3
Male	2	1	3

Outcome Measures

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1. Primary:

Number of Participants Considered Responders as Assessed During the Maintenance Period [ Time Frame: Baseline (Week -8/-4 to Week 0) and Maintenance Phase (Week 4 to Week 16) ]

Show Outcome Measure 1

2. Secondary:

Absolute Change From Baseline in 28-day PGTC Seizure Frequency [ Time Frame: Baseline and up to 16 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was terminated early at the Sponsor’s discretion. When this study was discontinued, only 6 subjects had been treated. Data from the 5 subjects treated with zonisamide were insufficient to draw firm conclusions regarding efficacy.

Results Point of Contact:

Name/Title: Antonio Laurenza, MD, Executive Director
Organization: Eisai Inc
phone: 1 201 949-4157
e-mail: antonio_laurenza@eisai.com

No publications provided

Responsible Party:	Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:	NCT00692003 History of Changes
Other Study ID Numbers:	E2090-E044-315, Eudra ID #2007-003557-91.
Study First Received:	June 3, 2008
Results First Received:	August 13, 2012
Last Updated:	September 11, 2012
Health Authority:	European Union: European Medicines Agency

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