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A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Zonisamide (Drug); Lamotrigine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Ya-Hui Cheng, Study Director, Affiliation: Eisai Taiwan

Summary

The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.

Clinical Details

Official title: A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline

Secondary outcome:

Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period

Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period

Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.

Eligibility

Minimum age: 16 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Subjects must sign and date the informed consent form

- Clinical diagnosis as refractory epilepsy

Exclusion criteria:

- Progressive neurologic disease

- Serious psychiatric disease

- Hemolytic anemia

- G6PD (glucose-6-phosphate dehydrogenase) deficiency

- Acute intermittent porphyrias

- Subjects who have received study drugs (Zonisamide, Lamotrigine) in the past

- Drug or alcohol addiction

- Renal impairment (serum creatinine ≧ 1. 5 mg/dl), or hepatic abnormality (ALT or AST >

2x ULN)

- Stevens-Johnson syndrome

- Progressive exfoliative dermatitis

- Pregnant, lactating or of childbearing potential female

- Regularly taking oral contraceptives

- Hypersensitivity to study drugs

- Severe cardiac disease (New York Heart Association Functional Class III and IV)

- History of malignancy within 5 years

- Taking valproic acid within 7 days prior to screening

- Subjects with simple partial seizures without motor component

Locations and Contacts

Changhua Christian Hospital, Changhua, Taiwan, China

Chang-Gung Memorial Hospital (CGMH), Kaohsiung, Taiwan, China

Chang-Gung Memorial Hospital (CGMH), Linkou, Taiwan, China

China Medical University Hospital (CMUH), Taichun, Taiwan, China

National Cheng Kung University Hospital, Tainan, Taiwan, China

Chang-Gung Memorial Hospital (CGMH), Taipei, Taiwan, China

Taipei Tzu Chi General Hospital, Taipei, Taiwan, China

Taipei Veterans General Hospital, Taipei, Taiwan, China

Additional Information

Starting date: March 2006
Last updated: May 13, 2013

Page last updated: August 23, 2015

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