A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.
Double-Blind, Parallel Comparison of Three Doses of Topiramate and Placebo in Refractory Partial Epilepsy
1 other identifier
interventional
188
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of topiramate as add-on therapy in patients with difficult to control partial onset seizures who are taking one or two standard antiepileptic drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 1988
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1988
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 1990
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedJune 8, 2011
January 1, 2011
October 7, 2005
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent reduction in the average monthly seizure rate from baseline to end of treatment
Secondary Outcomes (1)
Percent of patients responding to treatment (>= 50% reduction in seizure rate from baseline to end of treatment); patient's and investigator's global assessments at end of study; incidence of adverse events and safety are evaluated throughout study
Interventions
Eligibility Criteria
You may qualify if:
- History of simple or complex partial epilepsy that has been documented or witnessed
- during a 12-week baseline phase, patient must have at least 12 partial seizures while maintaining therapeutic levels of anti-epileptic drugs (AEDs)
- and have no more than one seizure-free interval of up to 3 weeks and none longer than 3 weeks
- good physical health.
You may not qualify if:
- Females who are capable of having children
- patients with treatable causes of seizures (for example, infections)
- patients with a progressive disorder of the nervous system
- patients with history of status epilepticus (repeated or prolonged seizures) while on antiepileptic therapy
- history of serious disease of the heart, liver, kidneys, gastrointestinal, metabolic, or endocrine system
- history of alcohol or drug abuse within one year prior to study initiation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
July 1, 1988
Study Completion
December 1, 1990
Last Updated
June 8, 2011
Record last verified: 2011-01