EpilepsyPhase 4NCT00266604
A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy
A Phase 4 study testing Topiramate in people with Epilepsy and Seizures, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Epilepsy, Seizures, Epilepsies, Partial
- What is being tested?
- Topiramate
- How many people
- 409 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients having new-onset epilepsy or epilepsy relapse characterized by partial-onset seizures or primary generalized tonic-clonic seizures
- having at least 1 seizure within the 3 months prior to entry
- who are previously untreated for epilepsy, previously treated for epilepsy, or if currently taking epilepsy medication, must have been taking it for less than 6 weeks
- weighing at least 25 kilograms (approximately 55 pounds)
- if female of childbearing potential, must be using an acceptable method of birth control
Who cannot join
- Patients who have previously taken topiramate for the treatment of epilepsy
- who are currently taking topiramate for any reason
- having active liver disease
- having a clinically significant medical condition or disease
- women who are pregnant or breastfeeding
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Topiramate
- Keywords
- Epilepsy, seizures, new-onset epilepsy, epilepsy relapse, epilepsy monotherapy
- Medical subject headings
- Epilepsy, Seizures, Epilepsies, Partial, Epilepsy, Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (1)
Influence of other patient characteristics on dose; Proportion of subjects remaining seizure-free; Time to stabilized dose; Reduction in seizure frequency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startDec 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266604
- Sponsor's protocol ID
- CR002869
- Status last verified
- Apr 2010
- First submitted
- 16 Dec 2005
- Last updated
- 10 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00266604
- Acronym / sponsor ID
- CR002869
- Keywords
- Epilepsy, seizures, new-onset epilepsy, epilepsy relapse, epilepsy monotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study start
- Dec 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients having new-onset epilepsy or epilepsy relapse characterized by partial-onset seizures or primary generalized tonic-clonic seizures
- having at least 1 seizure within the 3 months prior to entry
- who are previously untreated for epilepsy, previously treated for epilepsy, or if currently taking epilepsy medication, must have been taking it for less than 6 weeks
- weighing at least 25 kilograms (approximately 55 pounds)
- if female of childbearing potential, must be using an acceptable method of birth control
Key exclusion criteria (5 listed)
- Patients who have previously taken topiramate for the treatment of epilepsy
- who are currently taking topiramate for any reason
- having active liver disease
- having a clinically significant medical condition or disease
- women who are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramate | Drug | – |
Primary outcome
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
1 secondary outcome
Influence of other patient characteristics on dose; Proportion of subjects remaining seizure-free; Time to stabilized dose; Reduction in seizure frequency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Topamax Initiated as Monotherapy in Epilepsy (TIME) CSRLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate in people with Epilepsy and Seizures, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011; AzTrials last refreshed its copy on 27 Oct 2026.