EpilepsyPhase 2NCT00236873
A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.
A Phase 2 study testing topiramate in people with Epilepsy and Epilepsies, Partial, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of the study is to evaluate the efficacy and safety of topiramate in epilepsy patients with difficult to treat, partial-onset seizures who are taking one or two standard antiepileptic drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy, Epilepsies, Partial, Seizures
- What is being tested?
- topiramate
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Oct 1989to May 1993
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of simple or complex partial epilepsy that has been documented or witnessed
- an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy
- during an 8-week baseline phase, patient must have at least 8 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks
- and no seizure-free interval longer than 3 weeks
- good physical health.
Who cannot join
- Patients having solely generalized seizures or lacking documentation of partial epilepsy
- patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy
- generalized seizures, which are defined by the EEG wave pattern
- seizures that lack an abnormal pulsation pattern on EEG
- female patients who are pregnant or nursing, or those not using adequate birth control if capable of having children
About this study
Official title: Double-Blind Parallel Comparison of Topiramate 200 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy
The purpose of the study is to evaluate the efficacy and safety of topiramate in epilepsy patients with difficult to treat, partial-onset seizures who are taking one or two standard antiepileptic drugs.
Read the detailed description
Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," originating in both sides of the brain simultaneously, or "partial-onset," starting in one area of the brain. Antiepilepsy medications, such as topiramate, are selected based on seizure type. This is a double-blind, placebo-controlled study to evaluate topiramate efficacy and safety as add-on therapy in partial epilepsy patients. This study includes a baseline phase and a treatment phase. During the baseline phase (8 weeks duration), patients receive one or two standard antiepileptic drugs (AEDs), such as phenytoin, carbamazepine, phenobarbital, primidone, or valproic acid. Patients who continue to have seizures during treatment with standard AEDs proceed into the double-blind treatment phase. Patients then receive topiramate or placebo at a dosage of 100 milligrams once daily, increasing gradually over 3 weeks to 2 tablets twice daily (400 mg/day) or maximum tolerated dose, and maintained on that dose for 8 weeks (11 weeks is the total duration of the double-blind phase), while continuing on their standard AED regimen. Assessments of effectiveness include the percent reduction in the average monthly seizure rate, percent of patients responding to treatment (having equal to or greater than 50% reduction in seizure rate), and, the patient's and investigator's global assessments of medication at end of study. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, urinalysis), neurologic examinations, and vital sign measurements (blood pressure, pulse, temperature) weekly during the treatment phase. The study hypothesis is that topiramate, taken as add-on therapy to treatment with AEDs, will significantly reduce seizure frequency, compared with placebo, in patients with refractory partial epilepsy: that is, in patients who continue to have seizures despite treatment with a first-line AEDs. In addition, it is hypothesized that topiramate is well tolerated. Topiramate, 100 milligrams (mg) oral tablets (or placebo). Dosage begins at 100 mg once daily and increases gradually over 3 weeks to 2 tablets twice daily (400 mg/day, maximum) or maximum tolerated dose for an additional 8 weeks.
- Conditions
- Epilepsy, Epilepsies, Partial, Seizures
- Being tested
- topiramate
- Keywords
- topiramate, epilepsy, partial epilepsies, partial epilepsy, seizures, epileptic seizures, partial seizure disorder, brain diseases
- Medical subject headings
- Epilepsy, Epilepsies, Partial, Seizures, Brain Diseases
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.
Percent reduction in the average monthly seizure rate from baseline to end of treatment
Secondary outcomes (1)
Percent of patients responding to treatment. Percent reduction in generalized seizures. Patient's and investigator's global assessments at end of study and incidence of adverse events throughout study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startOct 1989
- Study completionMay 1993
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 47 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
- NCT00236873
- Sponsor's protocol ID
- CR005563
- Status last verified
- Apr 2010
- First submitted
- 7 Oct 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
Publications
Sharief M, Viteri C, Ben-Menachem E, Weber M, Reife R, Pledger G, Karim R. Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy. Epilepsy Res. 1996 Nov;25(3):217-24. doi: 10.1016/s0920-1211(96)00029-0.
PubMed 8956919
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Parallel Comparison of Topiramate 200 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy
- ClinicalTrials.gov ID
- NCT00236873
- Acronym / sponsor ID
- CR005563
- Conditions
- Epilepsy, Epilepsies, Partial, Seizures
- Keywords
- topiramate, epilepsy, partial epilepsies, partial epilepsy, seizures, epileptic seizures, partial seizure disorder, brain diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Oct 1989
- Study completion
- May 1993 (actual)
- First posted
- 12 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 purpose of the study is to evaluate the efficacy and safety of topiramate in epilepsy patients with difficult to treat, partial-onset seizures who are taking one or two standard antiepileptic drugs.
Detailed description
Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," originating in both sides of the brain simultaneously, or "partial-onset," starting in one area of the brain. Antiepilepsy medications, such as topiramate, are selected based on seizure type. This is a double-blind, placebo-controlled study to evaluate topiramate efficacy and safety as add-on therapy in partial epilepsy patients. This study includes a baseline phase and a treatment phase. During the baseline phase (8 weeks duration), patients receive one or two standard antiepileptic drugs (AEDs), such as phenytoin, carbamazepine, phenobarbital, primidone, or valproic acid. Patients who continue to have seizures during treatment with standard AEDs proceed into the double-blind treatment phase. Patients then receive topiramate or placebo at a dosage of 100 milligrams once daily, increasing gradually over 3 weeks to 2 tablets twice daily (400 mg/day) or maximum tolerated dose, and maintained on that dose for 8 weeks (11 weeks is the total duration of the double-blind phase), while continuing on their standard AED regimen. Assessments of effectiveness include the percent reduction in the average monthly seizure rate, percent of patients responding to treatment (having equal to or greater than 50% reduction in seizure rate), and, the patient's and investigator's global assessments of medication at end of study. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, urinalysis), neurologic examinations, and vital sign measurements (blood pressure, pulse, temperature) weekly during the treatment phase. The study hypothesis is that topiramate, taken as add-on therapy to treatment with AEDs, will significantly reduce seizure frequency, compared with placebo, in patients with refractory partial epilepsy: that is, in patients who continue to have seizures despite treatment with a first-line AEDs. In addition, it is hypothesized that topiramate is well tolerated. Topiramate, 100 milligrams (mg) oral tablets (or placebo). Dosage begins at 100 mg once daily and increases gradually over 3 weeks to 2 tablets twice daily (400 mg/day, maximum) or maximum tolerated dose for an additional 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of simple or complex partial epilepsy that has been documented or witnessed
- an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy
- during an 8-week baseline phase, patient must have at least 8 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks
- and no seizure-free interval longer than 3 weeks
- good physical health.
Key exclusion criteria (5 listed)
- Patients having solely generalized seizures or lacking documentation of partial epilepsy
- patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy
- generalized seizures, which are defined by the EEG wave pattern
- seizures that lack an abnormal pulsation pattern on EEG
- female patients who are pregnant or nursing, or those not using adequate birth control if capable of having children
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
Percent reduction in the average monthly seizure rate from baseline to end of treatment
1 secondary outcome
Percent of patients responding to treatment. Percent reduction in generalized seizures. Patient's and investigator's global assessments at end of study and incidence of adverse events throughout study.
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 8 Jun 2011.
- Results publication: PubMed 8956919Sharief M, Viteri C, Ben-Menachem E, Weber M, Reife R, Pledger G, Karim R. Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy. Epilepsy Res. 1996 Nov;25(3):217-24. doi: 10.1016/s0920-1211(96)00029-0.
- A study of the efficacy and safety of topiramate in the treatment of patients with epilepsyLink 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 2 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 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 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent reduction in the average monthly seizure rate from baseline to end of treatment. 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 NCT00236873, 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 8 Jun 2011.