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Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00327717
First received: May 17, 2006
Last updated: April 24, 2010
Last verified: September 2009
History of Changes
  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
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Zonisamide
U.S. FDA Resources

Further study details as provided by Eisai 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.

Enrollment: 240
Study Start Date: September 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Zonisamide
Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient; patients in PLB group were titrated with placebo in the same way as in ZNS group.
Other Name: Zonegran
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Locations
China, Beijing
The 1st hospital affiliated to Peking University
Beijing, Beijing, China, 100034
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Beijing Xuanwu Hospital
Beijing, Beijing, China
China, Shanghai
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Di Hong Eisai China Inc.
  More Information

No publications provided

Responsible Party: Shigekazu Takagi, Dainippon
ClinicalTrials.gov Identifier: NCT00327717     History of Changes
Other Study ID Numbers: E2090-AS086-311
Study First Received: May 17, 2006
Last Updated: April 24, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Eisai Inc.:
Epilepsy
Partial seizures

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Zonisamide
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013