A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy
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ClinicalTrials.gov Identifier: NCT00231556 |
Recruitment Status
:
Completed
First Posted
: October 4, 2005
Last Update Posted
: June 8, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy Seizures Epilepsies, Partial Epilepsy, Generalized Epilepsy, Tonic-Clonic | Drug: topiramate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 750 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Parallel-Group, Monotherapy Study to Compare the Safety and Efficacy of Two Doses of Topiramate in the Treatment of Newly Diagnosed or Recurrent Epilepsy |
Study Start Date : | July 1999 |
Actual Study Completion Date : | September 2003 |

- Time to first seizure (partial onset or generalized tonic-clonic seizure) during the core double-blind phase (excluding taper).
- Mean plasma topiramate levels for the high and low topiramate dosing groups; laboratory evaluations, vital signs, visual field testing results, and adverse events during trial

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Weigh >=25 kilograms
- Diagnosis of epilepsy within 3 months prior to study entry or recurrence of epilepsy while off of anit-epileptic drugs
- No more than two documented seizures during the three-month retrospective baseline phase
- may have experienced seizures prior to the three-month, retrospective baseline phase
- Patients with partial-onset seizures, with or without a secondarily generalized component, and generalized seizures, including tonic-clonic (grand mal), tonic, clonic, juvenile myoclonic epilepsy (impulsive petit mal) and myoclonic epilepsy
- Receiving either no other concomitant anti-epileptic drug (AED) or be on one standard AED.
Exclusion Criteria:
- Patients who do not have epilepsy
- Patients with absence (petit mal) or atypical absence seizures, epilepsia paritlis continua, cluster pattern or serial seizures
- Patients with progressive neurological or degenerative disorder
- Patients with significant history of unstable medical diseases
- Patients with a drug allergy or hypersensitivity to carbonic anhydrase inhibitors or sulfa drugs
- Patients with history of alcohol or drug abuse within past one year
- Patients with a history of suicide attempt within past one year.

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): NCT00231556
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: | NCT00231556 History of Changes |
Other Study ID Numbers: |
CR003259 |
First Posted: | October 4, 2005 Key Record Dates |
Last Update Posted: | June 8, 2011 |
Last Verified: | January 2010 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Epilepsy Seizures Parital Epilepsies |
Generalized Epilepsy Tonic-Clonic Epilepsy Topiramate |
Additional relevant MeSH terms:
Epilepsy Epilepsies, Partial Epilepsy, Generalized Epilepsy, Tonic-Clonic 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 |