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 Topiramate 400 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy
1 other identifier
interventional
56
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 epilepsy patients with difficult to treat, 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 P25-P50 for phase_2
Started May 1989
Typical duration for phase_2
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
May 1, 1989
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 1992
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedJune 8, 2011
April 1, 2010
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; patient's and investigator's global assessments at end of study rate; reduction in generalized seizureincidence 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
- an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy
- during an 8-week baseline phase, patient must have at least 8 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 no seizure-free interval 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)
Ben-Menachem E, Henriksen O, Dam M, Mikkelsen M, Schmidt D, Reid S, Reife R, Kramer L, Pledger G, Karim R. Double-blind, placebo-controlled trial of topiramate as add-on therapy in patients with refractory partial seizures. Epilepsia. 1996 Jun;37(6):539-43. doi: 10.1111/j.1528-1157.1996.tb00606.x.
PMID: 8641230RESULT
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
May 1, 1989
Study Completion
February 1, 1992
Last Updated
June 8, 2011
Record last verified: 2010-04