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.
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ClinicalTrials.gov Identifier: NCT00236691 |
Recruitment Status
:
Completed
First Posted
: October 12, 2005
Last Update Posted
: June 8, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy Epilepsies, Partial Seizures | Drug: topiramate | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 188 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Double-Blind, Parallel Comparison of Three Doses of Topiramate and Placebo in Refractory Partial Epilepsy |
Study Start Date : | July 1988 |
Actual Study Completion Date : | December 1990 |

- Percent reduction in the average monthly seizure rate from baseline to end of treatment
- Percent of patients responding to treatment (>= 50% reduction in seizure rate from baseline to end of treatment); patient's and investigator's global assessments at end of study; incidence of adverse events and safety are evaluated throughout study

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History of simple or complex partial epilepsy that has been documented or witnessed
- during a 12-week baseline phase, patient must have at least 12 partial seizures while maintaining therapeutic levels of anti-epileptic drugs (AEDs)
- and have no more than one seizure-free interval of up to 3 weeks and none longer than 3 weeks
- good physical health.
Exclusion Criteria:
- Females who are capable of having children
- patients with treatable causes of seizures (for example, infections)
- patients with a progressive disorder of the nervous system
- patients with history of status epilepticus (repeated or prolonged seizures) while on antiepileptic therapy
- history of serious disease of the heart, liver, kidneys, gastrointestinal, metabolic, or endocrine system
- history of alcohol or drug abuse within one year prior to study initiation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236691
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00236691 History of Changes |
Other Study ID Numbers: |
CR005452 |
First Posted: | October 12, 2005 Key Record Dates |
Last Update Posted: | June 8, 2011 |
Last Verified: | January 2011 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
topiramate epilepsy partial epilepsies partial epilepsy |
seizures epileptic seizures partial seizure disorder brain diseases |
Additional relevant MeSH terms:
Epilepsies, Partial Epilepsy Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations |
Signs and Symptoms Topiramate Anticonvulsants Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |