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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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01283256
First received: January 24, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Partial, Generalized and Combined Seizures
Drug: zonisamide
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Assess safety with zonisamide therapy in adult patients with different seizure types [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Assess reduction in seizure frequency with zonisamide therapy in adult patients with different seizure types [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate responder rates over 24 weeks of zonisamide treatment in adult patient with seizures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To evaluate seizure freedom over 24 weeks of zonisamide treatment in adult patient with seizures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 655
Study Start Date: January 2011
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Experimental Drug: zonisamide
zonisamide 100mg tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Single Cohort Study involving community patients with epilepsy

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283256

Locations
India
Hyderabad, Andhra Pradesh, India, 500057
Hyderabad, Andhra Pradesh, India, 500016
Hyderabad, Andhra Pradesh, India, 500027
Secunderabad, Andhra Pradesh, India, 500015
Secunderabad, Andhra Pradesh, India, 500003
Vijaywada, Andhra Pradesh, India
Vishakapatnam, Andhra Pradesh, India
Vishakhapatnam, Andhra Pradesh, India, 530002
Ahmedabad, Gujarat, India, 380009
Ahmedabad, Gujrat, India, 380015
Bangalore, Karanataka, India, 560010
Kochi, Kerela, India, 682301
Kochi, Kerela, India, 682012
Mumbai, Maharashtra, India, 400049
Mumbai, Maharashtra, India, 400012
Pune, Maharashtra, India
Jaipur, Rajastan, India, 302004
Jaipur, Rajastan, India, 302015
Jaipur, Rajastan, India, 302017
Chennai, Tamilnadu, India, 500017
Chennai, Tamilnadu, India, 600017
Chennai, Tamilnadu, India, 600006
Chennai, Tamilnadu, India, 600010
Lucknow, Uttar Pradesh, India, 226003
Lucknow, Uttar Pradesh, India, 226022
Noida, Uttar Pradesh, India, 201301
New Delhi, India, 110070
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Amitabh Dash Eisai Pharmaceuticals India Private limited
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01283256     History of Changes
Other Study ID Numbers: EIL/ZONE/CT01/2010
Study First Received: January 24, 2011
Last Updated: January 23, 2014
Health Authority: INDIA: Drugs Controller General of India, India

Additional relevant MeSH terms:
Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Zonisamide
Anticonvulsants
Antioxidants
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014