Epilepsy, Complex PartialPhase 3NCT00056576
Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
A Phase 3 study testing Zonisamide in people with Epilepsy, Complex Partial, run by Eisai Inc. at 35 sites in 5 countries.
Trial summary
The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Complex Partial
- What is being tested?
- Zonisamide
- How many people
- 165 participants
- Where
- 35 sitesin 5 countries
- Study dates
- Feb 2002to Oct 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
United States25 sites
Upstate Clinical Research Center
Albany, New York, 12205
St. Agnes Health Care, Inc.
Baltimore, Maryland, 21229
UAB Epilepsy Center
Birmingham, Alabama, 35294
The Comprehensive Epilepsy Care Center
Chesterfield, Missouri, 63017
River Hills Health Care
Cincinnati, Ohio, 45219
Neurology & Headache Specialist of Atlanta, LLC
Decatur, Georgia, 30033
CNS Research, INC
East Providence, Rhode Island, 02914
Westmoreland Neurology Associates, Inc.
Greensburg, Pennsylvania, 15601
North Alabama Neuroscience
Huntsville, Alabama, 35801
Louisville Neuroscience Research Center
Louisville, Kentucky, 40205
University of Wisconsin
Madison, Wisconsin, 53792
Neurology Associates
Maitland, Florida, 32751
Neurology Clinic, P.C.
Northport, Alabama, 35476
Northridge Neurological Center
Northridge, California, 91325
Dent Neurological Institute
Orchard Park, New York, 14127
Bay Neurological Institute
Panama City, Florida, 32405
Blue Ridge Research Center
Roanoke, Virginia, 24014
Neurology Clinic of San Antonio
San Antonio, Texas, 78229
Coordinated Clinical Research
San Diego, California, 92037
Southern Illinois University School of Medicine Dept. of Neurology
Springfield, Illinois, 62707
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701
Neurology & Neurosurgery Associates of Tacoma, Inc. P.S.
Tacoma, Washington, 98405
AMO Corporation
Tallahassee, Florida, 32308
Florida Epilepsy & Seizure Disorder Center, PA
Tampa, Florida, 33613
Epilepsy Institute of North Carolina
Winston-Salem, North Carolina, 27103
Ukraine4 sites
Kharkov State Medical University
Kharkiv, 31002
Institute of Neurology, Psychiatry, and Narcology of AMS Ukraine
Kharkiv, 31068
Epilepsy Center
Kiev, 254655
Odessa Medical University
Odesa, 9
Estonia2 sites
Tallinn Children's Hospital
Tallinn, 13419
Tartu University Hospital
Tartu, 13419
Hungary2 sites
Semmelweis University Health Science Faculty
Budapest, 116
National Institute of Neurosurgery Epilepsy Center
Budapest, H1145
Lithuania2 sites
Kaunas Medical University Clinics
Kaunas, 3007
Vilnius University Hospital
Vilnius, 2600
About this study
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
The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.
Read the detailed 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.
- Conditions
- Epilepsy, Complex Partial
- Being tested
- Zonisamide
- Keywords
- Monotherapy, Complex Partial Seizures, Epilepsy, anti-epilepsy drug, AED
- Medical subject headings
- Epilepsy, Complex Partial, Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonisamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2003 (estimated)
- Study startFeb 2002
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Complex PartialStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 165 participants
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056576
- Sponsor's protocol ID
- AN46046-304
- Status last verified
- Jul 2011
- First submitted
- 18 Mar 2003
- Last updated
- 18 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00056576
- Acronym / sponsor ID
- AN46046-304
- Conditions
- Epilepsy, Complex Partial
- Keywords
- Monotherapy, Complex Partial Seizures, Epilepsy, anti-epilepsy drug, AED
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 19 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zonisamide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zonisamide in people with Epilepsy, Complex Partial, run by Eisai Inc. at 35 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Ukraine, Estonia, Hungary, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2011.