A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00230698
First received: September 29, 2005
Last updated: November 12, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Epilepsy
Epilepsies, Partial
Seizures
Drug: topiramate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Topiramate (RWJ-17021-000) Monotherapy Clinical Trial in Patients With Recently Diagnosed Partial-Onset Seizures

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Laboratory, vital signs, electrocardiogram data and adverse events reported during the trial.

Enrollment: 451
Study Start Date: November 1995
Study Completion Date: August 2002
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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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: NCT00230698

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

Publications:
ClinicalTrials.gov Identifier: NCT00230698     History of Changes
Other Study ID Numbers: CR002503
Study First Received: September 29, 2005
Last Updated: November 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Epilepsy
Partial Epilepsies
Seizures
Topiramate

Additional relevant MeSH terms:
Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on October 19, 2014