A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy
Double-Blind Parallel Comparison of Three Doses of Topiramate and Placebo in Refractory Partial Epilepsy
1 other identifier
interventional
178
0 countries
N/A
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of topiramate as add-on therapy in patients with difficult to control partial onset seizures who are taking one or two standard anti-epileptic 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 Jun 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
June 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 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 antiepileptic 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:
- Patients having solely generalized seizures or lacking documentation of partial epilepsy
- patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy
- generalized seizures, which are defined by the EEG wave pattern
- seizures that lack an abnormal pulsation pattern on EEG
- females who are capable of having children
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Faught E, Wilder BJ, Ramsay RE, Reife RA, Kramer LD, Pledger GW, Karim RM. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages. Topiramate YD Study Group. Neurology. 1996 Jun;46(6):1684-90. doi: 10.1212/wnl.46.6.1684.
PMID: 8649570RESULT
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
June 1, 1988
Study Completion
December 1, 1990
Last Updated
June 8, 2011
Record last verified: 2011-01