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.

Partial, Generalized and Combined Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283256
• Other study ID #: EIL/ZONE/CT01/2010
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2011
• Last updated: January 23, 2014
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: INDIA: Drugs Controller General of India, India
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 655
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Partial, Generalized and Combined Seizures
• Seizures

Intervention

Drug:
• zonisamide
zonisamide 100mg tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess safety with zonisamide therapy in adult patients with different seizure types		24 weeks	No
Primary	Assess reduction in seizure frequency with zonisamide therapy in adult patients with different seizure types		24 weeks	No
Secondary	To evaluate responder rates over 24 weeks of zonisamide treatment in adult patient with seizures		24 weeks	No
Secondary	To evaluate seizure freedom over 24 weeks of zonisamide treatment in adult patient with seizures		24 weeks	No