A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy
TOPAMAX (Topiramate) Monotherapy Comparison Trial to Standard Monotherapy in the Treatment of Newly Diagnosed Epilepsy (RWJ-17021-000); Phase IIIB
1 other identifier
interventional
865
0 countries
N/A
Brief Summary
The purpose of this study is to compare the effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 1997
Typical duration for phase_3
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
September 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2000
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)
Time to first seizure from Day 15 of the study
Secondary Outcomes (1)
Time to first seizure from Day 1 of the study; time to exit from the study; proportion of seizure-free patients during the last 6 months of the double-blind period; safety evaluations conducted throughout the study
Interventions
Eligibility Criteria
You may qualify if:
- Body weight of at least 30 kilograms
- New epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry
- No history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks
- Females must be sexually abstinent, surgically sterile, or using adequate birth control measures, and have a negative pregnancy test before study entry
You may not qualify if:
- Patients who do not have epilepsy
- Have progressive or degenerative disorders (for example, certain hereditary conditions)
- Have a significant history (within last 2 years) of unstable medical diseases (heart, kidney, hormone, or liver diseases)
- Have mental retardation or other condition that could make interpretation of the study results difficult
- alcohol or drug abuse within the previous year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Wheless JW, Neto W, Wang S; EPMN-105 Study Group. Topiramate, carbamazepine, and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. J Child Neurol. 2004 Feb;19(2):135-41. doi: 10.1177/08830738040190020901.
PMID: 15072107RESULT
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 3
- 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
September 1, 1997
Study Completion
November 1, 2000
Last Updated
June 8, 2011
Record last verified: 2011-01