A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy
A Randomized, Double-Blind, Parallel-Group, Monotherapy Study to Compare the Safety and Efficacy of Two Doses of Topiramate in the Treatment of Newly Diagnosed or Recurrent Epilepsy
1 other identifier
interventional
750
0 countries
N/A
Brief Summary
The purpose of this study is to compare the safety and effectiveness of two doses of topiramate as monotherapy in the treatment of pediatric and adult patients with newly diagnosed or recurrent 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 Jul 1999
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
July 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedJune 8, 2011
January 1, 2010
September 30, 2005
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first seizure (partial onset or generalized tonic-clonic seizure) during the core double-blind phase (excluding taper).
Secondary Outcomes (1)
Mean plasma topiramate levels for the high and low topiramate dosing groups; laboratory evaluations, vital signs, visual field testing results, and adverse events during trial
Interventions
Eligibility Criteria
You may qualify if:
- Weigh \>=25 kilograms
- Diagnosis of epilepsy within 3 months prior to study entry or recurrence of epilepsy while off of anit-epileptic drugs
- No more than two documented seizures during the three-month retrospective baseline phase
- may have experienced seizures prior to the three-month, retrospective baseline phase
- Patients with partial-onset seizures, with or without a secondarily generalized component, and generalized seizures, including tonic-clonic (grand mal), tonic, clonic, juvenile myoclonic epilepsy (impulsive petit mal) and myoclonic epilepsy
- Receiving either no other concomitant anti-epileptic drug (AED) or be on one standard AED.
You may not qualify if:
- Patients who do not have epilepsy
- Patients with absence (petit mal) or atypical absence seizures, epilepsia paritlis continua, cluster pattern or serial seizures
- Patients with progressive neurological or degenerative disorder
- Patients with significant history of unstable medical diseases
- Patients with a drug allergy or hypersensitivity to carbonic anhydrase inhibitors or sulfa drugs
- Patients with history of alcohol or drug abuse within past one year
- Patients with a history of suicide attempt within past one year.
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
July 1, 1999
Study Completion
September 1, 2003
Last Updated
June 8, 2011
Record last verified: 2010-01