- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01283256
A Study to Evaluate the Safety and Efficacy of Zonisamide an Antiepileptic Drug as Monotherapy or Adjunctive Therapy in Treatment of Adult Patients With Partial, Generalized or Combined Seizures.
January 23, 2014 updated by: Eisai Inc.
Evaluation of Safety and Efficacy of Zonisamide in Adult Patients With Partial, Generalized and Combined Seizures: An Open Labeled, Non-comparative, Observational Study
The purpose of this study is to evaluate the safety and efficacy of zonisamide in the treatment of adult patients with partial, generalized or combined seizures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open labeled non-comparative, multicentric observational post marketing surveillance study to comparing the safety and efficacy of zonisamide as adjunctive therapy or monotherapy in patients with partial, generalized or combined seizures, in a initiating dose of 100mg/day titrated to a maximum of 600mg per day based on the seizure control and tolerability over a 24 weeks treatment period.
This study will include a total of 900 patients with partial, generalized or combined seizures across 30 centres in the country.
The patients will be enrolled based on the inclusion and exclusion criteria and will be evaluated for safety and efficacy at every 4 weekly interval for 24 weeks.
There will be total 7 study visits and the patients will be evaluated for clinically reportable adverse events, safety on Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale and for efficacy by evaluation of reduction in seizure frequency as the primary objective of the study.
For secondary objectives the patients data will be evaluated to determine the responder rates (> or = to 50% reduction in seizure frequency from baseline) and seizure freedom over the 24 weeks study period.
Study Type
Observational
Enrollment (Actual)
655
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Delhi, India, 110070
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500016
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Hyderabad, Andhra Pradesh, India, 500027
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Hyderabad, Andhra Pradesh, India, 500057
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Secunderabad, Andhra Pradesh, India, 500003
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Secunderabad, Andhra Pradesh, India, 500015
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Vijaywada, Andhra Pradesh, India
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Vishakapatnam, Andhra Pradesh, India
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Vishakhapatnam, Andhra Pradesh, India, 530002
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Gujarat
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Ahmedabad, Gujarat, India, 380009
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Gujrat
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Ahmedabad, Gujrat, India, 380015
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Karanataka
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Bangalore, Karanataka, India, 560010
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Kerela
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Kochi, Kerela, India, 682012
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Kochi, Kerela, India, 682301
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Maharashtra
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Mumbai, Maharashtra, India, 400012
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Mumbai, Maharashtra, India, 400049
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Pune, Maharashtra, India
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Rajastan
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Jaipur, Rajastan, India, 302004
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Jaipur, Rajastan, India, 302015
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Jaipur, Rajastan, India, 302017
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Tamilnadu
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Chennai, Tamilnadu, India, 500017
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Chennai, Tamilnadu, India, 600006
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Chennai, Tamilnadu, India, 600010
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Chennai, Tamilnadu, India, 600017
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226003
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Lucknow, Uttar Pradesh, India, 226022
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Noida, Uttar Pradesh, India, 201301
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Single Cohort Study involving community patients with epilepsy
Description
Inclusion Criteria:
- Male or female subjects, 18 to 75 years of age inclusive
Treated or untreated subjects suffering from any of the following types of seizures:
- Partial Seizures: Simple Partial Seizures, Complex Partial Seizures & Secondarily generalized tonic clonic seizures
- Generalized Seizures: Tonic-clonic seizures, tonic seizures & Atypical absence seizures
- Combined seizures (mixed)
- Subjects having had a computed tomography (CT) or magnetic resonance imaging (MRI) done within the last upto 10 years that ruled a progressive cause of epilepsy.
- Female subjects without child bearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible.
- Female subjects with childbearing potential must not be pregnant as confirmed by a negative pregnancy test at screening and enrollment must not be lactating and must be using a medically acceptable form of contraception, for the duration of the study and for one month following discontinuation of the study drug.
- Patients willing to take the medications as directed, maintain a seizure dairy, report adverse events and willing to come for the follow-ups as per schedule.
- Willing to comply with the protocol requirements.
- Able and willing to give the written informed consent.
Exclusion Criteria:
- Subjects with history of non-epileptic seizures (e.g. metabolic, pseudo-seizures).
- Subjects who have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation related seizures.
- Subjects with progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g. infection, demyelination or tumour).
- Subjects with a history of any significant or currently uncontrolled disease which in the opinion of the investigator will interfere with the conduct of this study or the assessment of safety & efficacy of the study drug.
- Subjects already receiving zonisamide therapy.
- Subjects who have received an investigational new drug or device in the past three months before screening and enrollment.
- Subjects with known hypersensitivity to zonisamide or sulphonamides.
- Subjects with known abnormal renal function (serum creatinine > 1.5 mg/dL) or abnormal hepatic function (Aspartate aminotransferase [AST] and alanine aminotransferase [ALT] > 2 times the upper normal limit).
- Subjects with a history of psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse.
- Subjects currently taking carbonic anhydrase inhibitors (acetazolamide).
- Subjects currently taking Mono-Amine Oxidase Inhibitor's (MAO-I's).
- Subjects having a history of pancreatitis, nephrolithiasis or hypercalciuria, clinically significant laboratory abnormalities suggestive of metabolic imbalance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Experimental
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zonisamide 100mg tablets
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Assess safety with zonisamide therapy in adult patients with different seizure types
Time Frame: 24 weeks
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24 weeks
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Assess reduction in seizure frequency with zonisamide therapy in adult patients with different seizure types
Time Frame: 24 weeks
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To evaluate responder rates over 24 weeks of zonisamide treatment in adult patient with seizures
Time Frame: 24 weeks
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24 weeks
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To evaluate seizure freedom over 24 weeks of zonisamide treatment in adult patient with seizures
Time Frame: 24 weeks
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amitabh Dash, Eisai Pharmaceuticals India Private limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
January 24, 2011
First Submitted That Met QC Criteria
January 24, 2011
First Posted (Estimate)
January 25, 2011
Study Record Updates
Last Update Posted (Estimate)
January 27, 2014
Last Update Submitted That Met QC Criteria
January 23, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EIL/ZONE/CT01/2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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