Partial, Generalized and Combined SeizuresNCT01283256
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.
An observational study of Partial, Generalized and Combined Seizures, run by Eisai Inc. at 27 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Partial, Generalized and Combined Seizures
- What is being tested?
- zonisamide
- Type of treatment
- Pill or oral medicine
- How many people
- 655 participants
- Where
- 27 sitesIndia
- Study dates
- Jan 2011to May 2013
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single Cohort Study involving community patients with epilepsy
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
India27 sites
Study site
Ahmedabad, Gujarat, 380009
Study site
Ahmedabad, Gujarat, 380015
Study site
Bangalore, Karnataka, 560010
Study site
Chennai, Tamil Nadu, 500017
Study site
Chennai, Tamil Nadu, 600006
Study site
Chennai, Tamil Nadu, 600010
Study site
Chennai, Tamil Nadu, 600017
Study site
Hyderabad, Andhra Pradesh, 500016
Study site
Hyderabad, Andhra Pradesh, 500027
Study site
Hyderabad, Andhra Pradesh, 500057
Study site
Jaipur, Rajasthan, 302004
Study site
Jaipur, Rajasthan, 302015
Study site
Jaipur, Rajasthan, 302017
Study site
Kochi, Kerala, 682012
Study site
Kochi, Kerala, 682301
Study site
Lucknow, Uttar Pradesh, 226003
Study site
Lucknow, Uttar Pradesh, 226022
Study site
Mumbai, Maharashtra, 400012
Study site
Mumbai, Maharashtra, 400049
Study site
New Delhi, New Delhi, 110070
Study site
Noida, Uttar Pradesh, 201301
Study site
Pune, Maharashtra
Study site
Secunderabad, Andhra Pradesh, 500003
Study site
Secunderabad, Andhra Pradesh, 500015
Study site
Vijaywada, Andhra Pradesh
Study site
Visakhapatnam, Andhra Pradesh, 530002
Study site
Visakhapatnam, Andhra Pradesh
About this study
Official title: 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.
Read the 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.
- Being tested
- zonisamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zonisamideDrug
zonisamide 100mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Not described Receives: Drug: zonisamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety with zonisamide therapy in adult patients with different seizure types
Measured: 24 weeks
Assess reduction in seizure frequency with zonisamide therapy in adult patients with different seizure types
Measured: 24 weeks
Secondary outcomes (2)
To evaluate responder rates over 24 weeks of zonisamide treatment in adult patient with seizures
Measured: 24 weeks
To evaluate seizure freedom over 24 weeks of zonisamide treatment in adult patient with seizures
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial, Generalized and Combined SeizuresStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amitabh Dash, Study director, Eisai Pharmaceuticals India Private limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283256
- Sponsor's protocol ID
- EIL/ZONE/CT01/2010
- Status last verified
- Jan 2014
- First submitted
- 24 Jan 2011
- Last updated
- 27 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Zonisamide in Adult Patients With Partial, Generalized and Combined Seizures: An Open Labeled, Non-comparative, Observational Study
- ClinicalTrials.gov ID
- NCT01283256
- Acronym / sponsor ID
- EIL/ZONE/CT01/2010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jan 2011 (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 evaluate the safety and efficacy of zonisamide in the treatment of adult patients with partial, generalized or combined seizures.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Drug: zonisamide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single Cohort Study involving community patients with epilepsy
Key inclusion criteria (11 listed)
- Male or female subjects, 18 to 75 years of age inclusive
- Treated or untreated subjects suffering from any of the following types of seizures:
- 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.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| zonisamidezonisamide 100mg tablets | Drug | Experimental |
Primary outcome
Assess safety with zonisamide therapy in adult patients with different seizure types
Time frame: 24 weeks
Assess reduction in seizure frequency with zonisamide therapy in adult patients with different seizure types
Time frame: 24 weeks
2 secondary outcomes
To evaluate responder rates over 24 weeks of zonisamide treatment in adult patient with seizures
Time frame: 24 weeks
To evaluate seizure freedom over 24 weeks of zonisamide treatment in adult patient with seizures
Time frame: 24 weeks
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 27 Jan 2014.
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.
Amitabh Dash study director
Eisai Pharmaceuticals India Private limited
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial, Generalized and Combined Seizures, run by Eisai Inc. at 27 sites in India.
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 12 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 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in India. 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.
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.
What does the primary outcome measure?
Assess safety with zonisamide therapy in adult patients with different seizure types (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 27 Jan 2014.