A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy
Topiramate (RWJ 17021-000) Clinical Trial In Children With Partial Onset Seizures
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of oral topiramate as add-on therapy in children with uncontrolled 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 below P25 for phase_3
Started Jun 1994
Longer than P75 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
June 1, 1994
CompletedStudy Completion
Last participant's last visit for all outcomes
October 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)
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); parent's or guardian's global assessments at beginning of treatment and end of study; incidence of adverse events throughout study
Interventions
Eligibility Criteria
You may qualify if:
- Patients must weigh at least 36 pounds (16 kilograms)
- patients must have partial onset seizures (with or without secondarily generalized seizures) being treated with at least one, but no more than two antiepileptic drugs (AEDs)
- patients must have at least 6 partial onset seizures during the 8-week baseline phase, with at least one seizure during each 4-week period
- an electroencephalogram (EEG) with features consistent with partial epilepsy performed prior to study initiation or during the baseline phase
You may not qualify if:
- Females who are pregnant, nursing, or those not using adequate birth control if capable of having children
- patients with a treatable cause of seizures (for example, infections)
- patients with a progressive disorder of the nervous system
- patients with a clinical diagnosis of Lennox-Gastaut syndrome
- patients with a history of generalized status epilepticus (repeated or prolonged seizures) while on appropriate anti-epileptic therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ritter F, Glauser TA, Elterman RD, Wyllie E. Effectiveness, tolerability, and safety of topiramate in children with partial-onset seizures. Topiramate YP Study Group. Epilepsia. 2000;41(S1):82-5. doi: 10.1111/j.1528-1157.2000.tb02178.x.
PMID: 10768307RESULT
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
June 1, 1994
Study Completion
October 1, 2000
Last Updated
June 8, 2011
Record last verified: 2011-01