A Multicenter, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizure

This study is not yet open for participant recruitment.

Verified by Eisai Medical Research Inc., May 2006

First Received: May 17, 2006 No Changes Posted

Sponsored by:	Eisai Limited
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00327717

Purpose

The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs).

Condition	Intervention	Phase
Partial Seizures	Drug: Zonisamide	Phase III

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures

Drug Information available for: Zonisamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

Median % reduction - the median percentage change from baseline in seizure frequency during the maintenance period.

Secondary Outcome Measures:

Response rate (%), the number of seizure-free days per 28 days, the median percent change of seizure-free days.

Estimated Enrollment:	240
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

According to the ILAE classification of seizure type (1981) and international classification of epilepsies and epileptic syndromes (ILAE, 1989), definite diagnosis of partial seizures (with or without secondary generalized seizures) refractory to current AED therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327717

Contacts

Contact: Yukihiko Yokobatake

y-yokobatake@hhc.eisai.co.jp

Locations

China
The 1st hospital affiliated to Peking University
Beijing, China, 100034
Peking Union Medical College Hospital
Beijing, China, 100730
Beijing Xuanwu Hospital
Beijing, China
Huashan Hospital affiliated to Fudan University
Shanghai, China, 200040

Sponsors and Collaborators

Eisai Limited

Investigators

Study Director:

Di Hong

Eisai China Inc.

More Information

No publications provided

Study ID Numbers:	E2090-AS086-301
Study First Received:	May 17, 2006
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00327717 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Antioxidants
Epilepsy
Zonisamide
Seizures

Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases
Anticonvulsants

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Seizures
Nervous System Diseases
Zonisamide
Physiological Effects of Drugs
Central Nervous System Diseases
Brain Diseases

Protective Agents
Pharmacologic Actions
Signs and Symptoms
Epilepsy
Therapeutic Uses
Neurologic Manifestations
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009