EpilepsyPhase 4TEAMSNCT01627860
First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients
A Phase 4 study testing Topiramate add-on therapy and Topiramate monotherapy in people with Epilepsy, run by Johnson & Johnson Taiwan Ltd.
Trial summary
The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Topiramate add-on therapy and Topiramate monotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Jan 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be diagnosed with seizure disorder
- Have been receiving concomitant therapy with one antiepileptic drug (AED), at stable dose prior to trial entry
- Must be dissatisfied with the current treatment
Who cannot join
- Have treatable cause of seizures (eg, metabolic disturbance, toxic exposure, an active infection, or neoplasm)
- Have grade IV astrocytomas, eg, Glioblastoma multiforme (GBM) or metastases with progression
- Have seizures occurring only in clustered patterns defined as numerous seizures occurring in less than 30 min
- Have had history (within past six months) of a psychiatric or mood disorder requiring electroconvulsive therapy, major tranquilizers, or monoamine oxidase inhibitors
- Have had schizophrenic or history of exhibiting psychotic symptomatology
- Inability to take medication or maintain a seizure calendar, independently or with assistance
About this study
Official title: Topiramate in the Treatment of Epilepsy: 1st Add-on vs. Mono-therapy Study in Neuro-Surgical Patients
The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.
Read the detailed description
This is a multicenter, randomized (treatment is assigned by chance), open-label (everyone who is involved in the trial knows the study drug), parallel group trial. The study has three phases: a retrospective baseline assessment of patients (4 weeks), titration period (8 weeks) and maintenance period (8 weeks). After qualifying for trial entry in the retrospective baseline phase, eligible patients will be randomized in 1:1 ratio to receive either topiramate add-on therapy or topiramate monotherapy. During the titration period (period in which the dose of the study drug is increased or decreased at the discretion of investigator), topiramate, given as morning doses, will be started with daily doses of 25 mg/day for one week. After that, topiramate will be given as morning and evening doses, and the doses will be gradually increased every week to reach the initial target dose of 200 mg/day at the end of titration period. During the maintenance period, the dose of topiramate could be increased or decreased according to the investigator's judgment. Patients should keep seizure diaries during the 16 weeks of topiramate treated period and are followed with once monthly visits to the clinic, at which safety will be evaluated.
- Conditions
- Epilepsy
- Being tested
- Topiramate add-on therapy, Topiramate monotherapy
- Keywords
- Epilepsy, Topiramate, Neuro-surgical patients, Nervous disorder, Seizures
- Medical subject headings
- Epilepsy, Nervous System Diseases, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate add-on therapyDrug
Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use.
Topiramate monotherapyDrug
Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use.
| Study group | Role | What they receive |
|---|---|---|
| Topiramate add-on therapy | Active comparator | Not described Receives: Drug: Topiramate add-on therapy |
| Topiramate monotherapy | Experimental | Not described Receives: Drug: Topiramate monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).
Measured: Month 4
Secondary outcomes (2)
Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4
Seizure frequency (seizure count/month) was calculated based on the number of seizure within a month. The mean seizure frequency analyzed by the ANCOVA model at each period.
Measured: Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4
Dosage Administration of Topamax During Month 4
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Taiwan Clinical Trial, Study director, Janssen-Cilag Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627860
- Sponsor's protocol ID
- CR017248
- Other IDs
- TOPMATEPY4061, TOP-TWN-MA4
- Acronym
- TEAMS
- Status last verified
- Sep 2013
- First submitted
- 31 May 2012
- Last updated
- 29 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate in the Treatment of Epilepsy: 1st Add-on vs. Mono-therapy Study in Neuro-Surgical Patients
- ClinicalTrials.gov ID
- NCT01627860
- Acronym / sponsor ID
- TEAMS / CR017248
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Topiramate, Neuro-surgical patients, Nervous disorder, Seizures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Posted 24 May 2013
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 examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.
Detailed description
This is a multicenter, randomized (treatment is assigned by chance), open-label (everyone who is involved in the trial knows the study drug), parallel group trial. The study has three phases: a retrospective baseline assessment of patients (4 weeks), titration period (8 weeks) and maintenance period (8 weeks). After qualifying for trial entry in the retrospective baseline phase, eligible patients will be randomized in 1:1 ratio to receive either topiramate add-on therapy or topiramate monotherapy. During the titration period (period in which the dose of the study drug is increased or decreased at the discretion of investigator), topiramate, given as morning doses, will be started with daily doses of 25 mg/day for one week. After that, topiramate will be given as morning and evening doses, and the doses will be gradually increased every week to reach the initial target dose of 200 mg/day at the end of titration period. During the maintenance period, the dose of topiramate could be increased or decreased according to the investigator's judgment. Patients should keep seizure diaries during the 16 weeks of topiramate treated period and are followed with once monthly visits to the clinic, at which safety will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate add-on therapy | Active comparator | Drug: Topiramate add-on therapy |
| Topiramate monotherapy | Experimental | Drug: Topiramate monotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be diagnosed with seizure disorder
- Have been receiving concomitant therapy with one antiepileptic drug (AED), at stable dose prior to trial entry
- Must be dissatisfied with the current treatment
Key exclusion criteria (6 listed)
- Have treatable cause of seizures (eg, metabolic disturbance, toxic exposure, an active infection, or neoplasm)
- Have grade IV astrocytomas, eg, Glioblastoma multiforme (GBM) or metastases with progression
- Have seizures occurring only in clustered patterns defined as numerous seizures occurring in less than 30 min
- Have had history (within past six months) of a psychiatric or mood disorder requiring electroconvulsive therapy, major tranquilizers, or monoamine oxidase inhibitors
- Have had schizophrenic or history of exhibiting psychotic symptomatology
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 add-on therapyType=range, unit=mg/day, number=25-200, form=tablet, route=oral use. | Drug | Topiramate add-on therapy |
| Topiramate monotherapyType= range, unit= mg/day, number= 25-200, form= tablet, route= oral use. | Drug | Topiramate monotherapy |
Primary outcome
Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).
Time frame: Month 4
2 secondary outcomes
Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4
Time frame: Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4
Dosage Administration of Topamax During Month 4
Time frame: Month 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janssen-Cilag Taiwan Clinical Trial study director
Janssen-Cilag Taiwan
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate add-on therapy and Topiramate monotherapy in people with Epilepsy, run by Johnson & Johnson Taiwan Ltd.
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 3 inclusion and 6 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 29 Oct 2013. 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?
Yes. Results are posted in the registry (first posted 24 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4). (time frame: Month 4). 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 29 Oct 2013.