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.

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236873
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Epilepsy
Epilepsies, Partial
Seizures
Drug: topiramate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind Parallel Comparison of Topiramate 200 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Percent reduction in the average monthly seizure rate from baseline to end of treatment

Secondary Outcome Measures:
  • 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.

Enrollment: 47
Study Start Date: October 1989
Study Completion Date: May 1993
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236873

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00236873     History of Changes
Other Study ID Numbers: CR005563
Study First Received: October 7, 2005
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

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
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014