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Completed

NCT Number: NCT00292461

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Changhua Christian Hospital, Changhua, Taiwan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zonisamide

Drug

Tablet once or twice daily orally for 16 weeks

Lamotrigine

Drug

Tablet once daily orally for 16 weeks

Primary outcomes

  1. The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline

    Time frame: Baseline and 16 weeks

    Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment

Secondary outcomes

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

    Time frame: Baseline and 16 weeks

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

    Time frame: Baseline and 16 weeks

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

    Time frame: Baseline and 16 weeks

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 16, 2006
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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