EpilepsyPhase 3NCT00230698
A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure
A Phase 3 study testing topiramate in people with Epilepsy and Epilepsies, Partial, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purposes of this study are (1) to compare the effectiveness of two doses of topiramate and (2) to assess the safety of topiramate alone in the treatment of pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Epilepsy, Epilepsies, Partial, Seizures
- What is being tested?
- topiramate
- How many people
- 451 participants
- Where
- No sites listed yet
- Study dates
- Nov 1995to Aug 2002
- Phase
- Phase 3
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Body weight between 25 kg and 110 kg (approximately 55-240 lb)
- Diagnosis of epilepsy characterized by unprovoked partial-onset seizures that were diagnosed within the past three years
- During the three-month Retrospective Baseline Phase, patients must have had at least one seizure, have had an average of no more than two seizures per month, and have had no more than three seizures in any given month. None of the seizures should occur in a cluster pattern
- During the three-month Retrospective Baseline Phase, patients must receive either no other standard Anti-Epileptic Drug (AED), or be on one AED
- Patients currently on one AED must be considered inadequately controlled
- Must have evidence from computed tomography (CT) or magnetic resonance imaging (MRI) of the absence of an arteriovenous malformation or a progressive lesion such as a tumor.
Who cannot join
- Patients who do not have epilepsy, such as patients with pseudoseizures or a treatable cause of seizures
- Patients with benign rolandic epilepsy
- Patients with progressive or degenerative disorders
- Patients with a documented history of generalized tonic-clonic status epilepticus during the three month Retrospective Baseline Phase
- Patients with a significant history (within the past two years) of medical disease that may impair their reliable participation in the trial or necessitate the use of medication not allowed by this protocol
- Patients who are unable to take their medication either independently or with assistance.
About this study
Official title: Topiramate (RWJ-17021-000) Monotherapy Clinical Trial in Patients With Recently Diagnosed Partial-Onset Seizures
The purposes of this study are (1) to compare the effectiveness of two doses of topiramate and (2) to assess the safety of topiramate alone in the treatment of pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures.
Read the detailed description
Topiramate is approved for treating epilepsy in combination with other epilepsy drugs, but not approved for treating epilepsy as sole treatment or in recently diagnosed epilepsy characterized by partial-onset seizures. This is a randomized, double-blind, parallel-group, multicenter trial to investigate the effectiveness and safety of topiramate in pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures. There are four phases of this trial: Retrospective Baseline, Open-Treatment, Double-Blind, and Long-Term Extension. During the Retrospective Baseline Phase, eligibilities of the potential patients are evaluated. During the Open-Treatment Phase, patients receive 25 milligrams[mg] daily of topiramate to assess their ability to tolerate the medication. During the Double-Blind Phase, patients are randomized to a high or a low dose of topiramate. Patients continue to receive the study medication until one of the following occurs: (1) treatment fails; (2) 4 months have passed since the last patient was randomized; or (3) the patient withdraws from the study. Unless withdrawn from the study, the patient may enter the Long-Term Extension Phase and receive high dose topiramate (maximum of either 1,600mg daily for patients >= 14 years of age, or 24mg/kilogram[kg] for patients < 14 years of age) until the patient withdraws or the study is stopped by the sponsor. The study hypothesis is that topiramate will be effective and well tolerated in treating pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures. Open-Treatment: topiramate 25mg daily by mouth for 7days. Double-Blind: low dose (50 mg or 25mg daily, depending on body weight) or high dose (500mg or 200mg daily, depending on body weight) for up to 4 months. Long-Term Extension: high dose (1600mg or 24mg/kg daily, maximum) for various duration.
- Conditions
- Epilepsy, Epilepsies, Partial, Seizures
- Being tested
- topiramate
- Keywords
- Epilepsy, Partial Epilepsies, Seizures, Topiramate
- Medical subject headings
- Epilepsy, Epilepsies, Partial, Seizures
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.
Time to exit during the double blind phase (2 partial onset seizures with or without a secondarily generalized component, a secondarily generalized tonic clonic seizure when none existed prior to this phase, or 1 episode of status epilepticus).
Secondary outcomes (1)
Laboratory, vital signs, electrocardiogram data and adverse events reported during the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startNov 1995
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- NCT00230698
- Sponsor's protocol ID
- CR002503
- Status last verified
- Nov 2010
- First submitted
- 29 Sep 2005
- Last updated
- 15 Nov 2010
- Results posted
- No
Publications
Gilliam FG, Veloso F, Bomhof MA, Gazda SK, Biton V, Ter Bruggen JP, Neto W, Bailey C, Pledger G, Wu SC. A dose-comparison trial of topiramate as monotherapy in recently diagnosed partial epilepsy. Neurology. 2003 Jan 28;60(2):196-202. doi: 10.1212/01.wnl.0000048200.12663.bc.
PubMed 12552030
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate (RWJ-17021-000) Monotherapy Clinical Trial in Patients With Recently Diagnosed Partial-Onset Seizures
- ClinicalTrials.gov ID
- NCT00230698
- Acronym / sponsor ID
- CR002503
- Conditions
- Epilepsy, Epilepsies, Partial, Seizures
- Keywords
- Epilepsy, Partial Epilepsies, Seizures, Topiramate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Nov 1995
- Study completion
- Aug 2002 (actual)
- First posted
- 3 Oct 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 purposes of this study are (1) to compare the effectiveness of two doses of topiramate and (2) to assess the safety of topiramate alone in the treatment of pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures.
Detailed description
Topiramate is approved for treating epilepsy in combination with other epilepsy drugs, but not approved for treating epilepsy as sole treatment or in recently diagnosed epilepsy characterized by partial-onset seizures. This is a randomized, double-blind, parallel-group, multicenter trial to investigate the effectiveness and safety of topiramate in pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures. There are four phases of this trial: Retrospective Baseline, Open-Treatment, Double-Blind, and Long-Term Extension. During the Retrospective Baseline Phase, eligibilities of the potential patients are evaluated. During the Open-Treatment Phase, patients receive 25 milligrams[mg] daily of topiramate to assess their ability to tolerate the medication. During the Double-Blind Phase, patients are randomized to a high or a low dose of topiramate. Patients continue to receive the study medication until one of the following occurs: (1) treatment fails; (2) 4 months have passed since the last patient was randomized; or (3) the patient withdraws from the study. Unless withdrawn from the study, the patient may enter the Long-Term Extension Phase and receive high dose topiramate (maximum of either 1,600mg daily for patients >= 14 years of age, or 24mg/kilogram[kg] for patients < 14 years of age) until the patient withdraws or the study is stopped by the sponsor. The study hypothesis is that topiramate will be effective and well tolerated in treating pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures. Open-Treatment: topiramate 25mg daily by mouth for 7days. Double-Blind: low dose (50 mg or 25mg daily, depending on body weight) or high dose (500mg or 200mg daily, depending on body weight) for up to 4 months. Long-Term Extension: high dose (1600mg or 24mg/kg daily, maximum) for various duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Body weight between 25 kg and 110 kg (approximately 55-240 lb)
- Diagnosis of epilepsy characterized by unprovoked partial-onset seizures that were diagnosed within the past three years
- During the three-month Retrospective Baseline Phase, patients must have had at least one seizure, have had an average of no more than two seizures per month, and have had no more than three seizures in any given month. None of the seizures should occur in a cluster pattern
- During the three-month Retrospective Baseline Phase, patients must receive either no other standard Anti-Epileptic Drug (AED), or be on one AED
- Patients currently on one AED must be considered inadequately controlled
Key exclusion criteria (6 listed)
- Patients who do not have epilepsy, such as patients with pseudoseizures or a treatable cause of seizures
- Patients with benign rolandic epilepsy
- Patients with progressive or degenerative disorders
- Patients with a documented history of generalized tonic-clonic status epilepticus during the three month Retrospective Baseline Phase
- Patients with a significant history (within the past two years) of medical disease that may impair their reliable participation in the trial or necessitate the use of medication not allowed by this protocol
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
Time to exit during the double blind phase (2 partial onset seizures with or without a secondarily generalized component, a secondarily generalized tonic clonic seizure when none existed prior to this phase, or 1 episode of status epilepticus).
1 secondary outcome
Laboratory, vital signs, electrocardiogram data and adverse events reported during the trial.
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 15 Nov 2010.
- Results publication: PubMed 12552030Gilliam FG, Veloso F, Bomhof MA, Gazda SK, Biton V, Ter Bruggen JP, Neto W, Bailey C, Pledger G, Wu SC. A dose-comparison trial of topiramate as monotherapy in recently diagnosed partial epilepsy. Neurology. 2003 Jan 28;60(2):196-202. doi: 10.1212/01.wnl.0000048200.12663.bc.
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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 3 study testing topiramate in people with Epilepsy and Epilepsies, Partial, 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 6 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 15 Nov 2010. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to exit during the double blind phase (2 partial onset seizures with or without a secondarily generalized component, a secondarily generalized tonic clonic seizure when none existed prior to this phase, or 1 episode of status epilepticus).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00230698, which also lists 1 linked publication.
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 15 Nov 2010.