Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy

Epilepsy, Complex Partial Clinical Trial

Official title:

A Double-Blind, Randomized, Multicenter, Parallel Group Study to Establish Dose-Response, Safety, and Efficacy of Zonegran (Zonisamide) as Monotherapy in Patients With Newly Diagnosed Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056576
• Other study ID #: AN46046-304
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2003
• Last updated: July 14, 2011
• Start date: February 2002
• Est. completion date: October 2004

Study information

• Verified date: July 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.

Description:

Epilepsy is characterized by repeated seizures caused by recurrent, abnormal, and excessive synchronous discharges from cerebral neurons. Seizures may be triggered by various causes such as CNS infections, fever, tumors, toxins, vascular disease, degenerative disease, trauma, or may be idiopathic. The type of seizure is usually defined by the initial event, the duration, alterations of consciousness, patterns of motor activity, and post-ictal symptoms. In addition, certain seizure types have characteristic EEG patterns. The International Classification of Epileptic Seizures classifies seizures as partial or generalized. Partial seizures are further classified as simple partial, complex partial (impaired consciousness), or partial seizures secondarily generalized. All partial seizures have onset in a discrete cortical region. Generalized seizures are bilaterally symmetrical and without focal onset and include absence seizures, myoclonic seizures, clonic seizures, tonic seizures, tonic-clonic seizures, and atonic seizures. The goals of treatment include the prevention of seizures, medical management of seizures, and management of the consequences of epilepsy. The study will be conducted with patients who have new onset epilepsy characterized by complex partial seizures and will attempt to characterize the relationship between zonisamide dose and seizure prevention and demonstrate monotherapy efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

INCLUSION CRITERIA

• Patient able and willing to give written informed consent or assent as appropriate in accordance with ICH and GCP guidelines

• Patient with newly diagnosed epilepsy who has complex partial seizures (with or without secondary generalization)

• Patient must have at least two well-documented, unprovoked, clinically evaluated and classified complex partial seizures or one well-documented, unprovoked, clinically evaluated and classified complex partial seizure and an abnormal EEG consistent with the diagnosis of epilepsy occurring within one year prior to enrollment

• Patient must have received less than 2 weeks of prior AED therapy, which will be discontinued at study entry

• EEG changes consistent with the diagnosis of epilepsy:

• For patients with two well-documented, unprovoked complex partial seizures within one year prior to enrollment, the EEG results may be normal at the time of testing but, in the opinion of the Investigator, the patient has epilepsy

• For patients with one well-documented, unprovoked complex partial seizure within one year prior to enrollment, the EEG must be abnormal at the time of testing consistent with the diagnosis of epilepsy

• Patient age 16 years or greater

• In the opinion of the Investigator, the patient is in good health

• Female patients of child-bearing potential must not be pregnant (serum HCG negative) or lactating, and must be using a medically acceptable form of birth control such as abstinence, an adequate barrier method, or hormonal contraceptive; or female patients who are post-menopausal or have had surgical sterilization

• Patient or caregiver able to follow Investigator instruction, study procedures, maintain diary of concomitant medication use, and report adverse events

EXCLUSION CRITERIA

• History of status epilepticus

• Patient with simple partial seizures only

• A history of non-epileptic seizures (e.g. metabolic or pseudo-seizures)

• Progressive encephalopathy or findings consistent with progressive CNS disease or lesions (e.g. infection, demyelination, tumor)

• Clinically significant uncontrolled medical disease in the previous two years (including unstable cardiac, hematological, hepatic, or renal disease)

• History of acute intermittent porphyria, glucose-6-phosphate dehydrogenase deficiency or hemolytic anemia

• Renal insufficiency (serum creatinine > 2 mg/dL) or impaired liver function (SGPT/ALT > two times upper limit of normal)

• History of renal calculi

• Laboratory test results which, in the opinion of the Investigator, are clinically significant abnormalities

• History of alcohol or drug abuse

• Psychiatric illness or mood disorders requiring treatment in previous 6 months; history of suicide attempt or psychosis

• Use of benzodiazepines (intermittent use as a hypnotic or an PRN AED is allowed)

• Use of other investigational compounds, experimental drugs or devices within 30 days of the screening visit

• History of hypersensitivity or allergic reaction to sulfonamides

• Medical disorder, surgery or medication that might interfere with absorption, distribution, metabolism, or excretion of the study drug

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Complex Partial

Intervention

Drug:
• Zonisamide

Locations

Country	Name	City	State
Estonia	Tallinn Children's Hospital	Tallinn
Estonia	Tartu University Hospital	Tartu
Hungary	National Institute of Neurosurgery Epilepsy Center	Budapest
Hungary	Semmelweis University Health Science Faculty	Budapest
Lithuania	Kaunas Medical University Clinics	Kaunas
Lithuania	Vilnius University Hospital	Vilnius
Ukraine	Institute of Neurology, Psychiatry, and Narcology of AMS Ukraine	Kharkov
Ukraine	Kharkov State Medical University	Kharkov
Ukraine	Epilepsy Center	Kiev
Ukraine	Odessa Medical University	Odessa
United States	Upstate Clinical Research Center	Albany	New York
United States	St. Agnes Health Care, Inc.	Baltimore	Maryland
United States	UAB Epilepsy Center	Birmingham	Alabama
United States	The Comprehensive Epilepsy Care Center	Chesterfield	Missouri
United States	River Hills Health Care	Cincinnati	Ohio
United States	Neurology & Headache Specialist of Atlanta, LLC	Decatur	Georgia
United States	CNS Research, INC	East Providence	Rhode Island
United States	Westmoreland Neurology Associates, Inc.	Greensburg	Pennsylvania
United States	North Alabama Neuroscience	Huntsville	Alabama
United States	Louisville Neuroscience Research Center	Louisville	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Neurology Associates	Maitland	Florida
United States	Neurology Clinic, P.C.	Northport	Alabama
United States	Northridge Neurological Center	Northridge	California
United States	Dent Neurological Institute	Orchard Park	New York
United States	Bay Neurological Institute	Panama City	Florida
United States	Blue Ridge Research Center	Roanoke	Virginia
United States	Neurology Clinic of San Antonio	San Antonio	Texas
United States	Coordinated Clinical Research	San Diego	California
United States	Southern Illinois University School of Medicine Dept. of Neurology	Springfield	Illinois
United States	Suncoast Neuroscience Associates, Inc.	St. Petersburg	Florida
United States	Neurology & Neurosurgery Associates of Tacoma, Inc. P.S.	Tacoma	Washington
United States	AMO Corporation	Tallahassee	Florida
United States	Florida Epilepsy & Seizure Disorder Center, PA	Tampa	Florida
United States	Epilepsy Institute of North Carolina	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Estonia,  Hungary,  Lithuania,  Ukraine,