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Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy

NCT00693017 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-12-24

Study results available
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Summary

This study is intended to provide evidence that zonisamide is safe and effective in the treatment of myoclonic seizures. The total planned trial duration will be 6.5 months. After that, subjects who have completed the study will be eligible to enroll in an open-label extension study until zonisamide is marketed for this indication or further development in this indication stops. This extension study will be described in a separate protocol (E2090-E044-318).

Conditions

Interventions

DRUG

Zonisamide

50-400 mg capsules once daily in the evening orally. Maximum study duration 28 weeks comprising: Baseline Period (Week -8 to Week 0): no treatment Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events) Down Titration Period (4 Weeks)

DRUG

Placebo

50-400 mg Zonisamide Placebo capsules once daily in the evening orally. Maximum study duration 28 weeks comprising: Baseline Period (Week -8 to Week 0): no treatment Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events) Down Titration Period (4 Weeks)

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Principal Investigators

  • Rob van Maanen, M.D. · Eisai Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-11-30

Countries

  • Australia
  • Croatia
  • Czechia
  • Estonia
  • Finland
  • Germany
  • Hungary
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Serbia
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00693017 on ClinicalTrials.gov