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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01283256 |
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Date of registration:
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24/01/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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Evaluation of Safety and Efficacy of Zonisamide in Adult Patients With Partial, Generalized and Combined Seizures: An Open Labeled, Non-comparative, Observational Study |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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655 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01283256 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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India
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Contacts
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Name:
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Amitabh Dash |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eisai Pharmaceuticals India Private limited |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female subjects, 18 to 75 years of age inclusive
2. Treated or untreated subjects suffering from any of the following types of seizures:
1. Partial Seizures: Simple Partial Seizures, Complex Partial Seizures &
Secondarily generalized tonic clonic seizures
2. Generalized Seizures: Tonic-clonic seizures, tonic seizures & Atypical
absence seizures
3. Combined seizures (mixed)
3. 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.
4. Female subjects without child bearing potential (2 years postmenopausal, bilateral
oophorectomy or tubal ligation, complete hysterectomy) are eligible.
5. 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.
6. 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.
7. Willing to comply with the protocol requirements.
8. Able and willing to give the written informed consent.
Exclusion Criteria:
1. Subjects with history of non-epileptic seizures (e.g. metabolic, pseudo-seizures).
2. Subjects who have experienced seizures relating to drugs, alcohol, acute medical
illness, mental retardation, or subjects with situation related seizures.
3. Subjects with progressive encephalopathy or findings consistent with progressive CNS
disease or lesion (e.g. infection, demyelination or tumour).
4. 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.
5. Subjects already receiving zonisamide therapy.
6. Subjects who have received an investigational new drug or device in the past three
months before screening and enrollment.
7. Subjects with known hypersensitivity to zonisamide or sulphonamides.
8. 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).
9. 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.
10. Subjects currently taking carbonic anhydrase inhibitors (acetazolamide).
11. Subjects currently taking Mono-Amine Oxidase Inhibitor's (MAO-I's).
12. Subjects having a history of pancreatitis, nephrolithiasis or hypercalciuria,
clinically significant laboratory abnormalities suggestive of metabolic imbalance
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Partial, Generalized and Combined Seizures
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Intervention(s)
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Drug: zonisamide
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Primary Outcome(s)
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Assess safety with zonisamide therapy in adult patients with different seizure types
[Time Frame: 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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Secondary Outcome(s)
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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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To evaluate responder rates over 24 weeks of zonisamide treatment in adult patient with seizures
[Time Frame: 24 weeks]
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Secondary ID(s)
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EIL/ZONE/CT01/2010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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