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| Tracking Information | |||||
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| First Received Date ICMJE | December 16, 2005 | ||||
| Last Updated Date | September 18, 2009 | ||||
| Start Date ICMJE | December 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Comparison of the mean stabilized topiramate dose during the last 28 days of treatment between patients reporting 1 to 3 seizures versus patients reporting more than 3 seizures, during the 3 months prior to study entry | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00266604 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Influence of other patient characteristics on dose; Proportion of subjects remaining seizure-free; Time to stabilized dose; Reduction in seizure frequency | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy | ||||
| Official Title ICMJE | TOPAMAX� (Topiramate) Initiated as Monotherapy in Epilepsy (TIME): A Multicenter, Outpatient, Open-Label, Study to Evaluate the Dosing, Effectiveness and Safety of TOPAMAX� as Monotherapy in the Treatment of Epilepsy in Clinical Practice | ||||
| Brief Summary | The purpose of this study is to identify patient characteristics (such as baseline seizure frequency) that may predict effective doses of topiramate using just that one drug (monotherapy) as initial therapy for epilepsy. Topiramate is an anti-epileptic drug that is approved for the treatment of epilepsy in adults and children 2 years of age and above. |
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| Detailed Description | Any number of factors could affect the dosage needs for an anti-epileptic medication, however, various lines of evidence suggest that characteristics of the patient's epilepsy itself could be important determinants. Baseline (i.e., at the start of the study) patient characteristics, particularly seizure frequency, may predict dosage needs when TOPAMAX® (topiramate) is initiated as monotherapy and titrated to an individualized optimal dose. Topiramate is an anti-epileptic drug that is approved for epilepsy either alone (i.e., monotherapy), or in combination with other anti-epileptic medications, in adults and children 2 years of age and above. This is a multicenter, outpatient, open-label, single-arm study to evaluate the dosing, tolerability, effectiveness and safety of topiramate as initial therapy for epilepsy in clinical practice. Patients who have been identified by their physicians as candidates for initial anti-epileptic monotherapy will be enrolled. Patients will begin therapy with topiramate tablets starting at 50 milligrams per day and be titrated to an individualized optimal dose, up to a maximum of 400 milligrams per day, by the end of week 6. Changes to this schedule will be based on a risk-benefit assessment of the patient's clinical condition by the investigator, such as tolerability, or reaching a stable dose sufficient to control their seizures. Treatment with topiramate will last for a total of 24 weeks. The primary outcome of the study is a comparison of the mean stabilized topiramate dose during the last 28 days of treatment for patients reporting 1 to 3 seizures during the 3 months prior to study entry versus patients reporting more than 3 seizures during the 3 months prior to study entry. The study hypothesis is that the average stabilized dose of topiramate will be lower in patients that have had fewer seizures in the 3 months prior to beginning the study. Topiramate tablets starting at 50 milligrams per day and titrated to an individualized optimal dose, up to a maximum of 400 milligrams per day by the end of week 6. Patients will take topiramate tablets by mouth twice a day (morning and evening) for 24 weeks. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Topiramate | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 409 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 10 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00266604 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CR002869 | ||||
| Study Sponsor ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
| Collaborators ICMJE | Ortho-McNeil Neurologics, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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