A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236717
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to compare the effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.


Condition Intervention Phase
Epilepsy
Seizures
Drug: Topiramate; Carbamazepine; Valproate
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: TOPAMAX (Topiramate) Monotherapy Comparison Trial to Standard Monotherapy in the Treatment of Newly Diagnosed Epilepsy (RWJ-17021-000); Phase IIIB

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to first seizure from Day 15 of the study

Secondary Outcome Measures:
  • Time to first seizure from Day 1 of the study; time to exit from the study; proportion of seizure-free patients during the last 6 months of the double-blind period; safety evaluations conducted throughout the study

Enrollment: 865
Study Start Date: September 1997
Study Completion Date: November 2000
Detailed Description:

Topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients (2 to 16 years of age). This is a randomized, double-blind, parallel-group study to evaluate the effectiveness and safety of two dosages of topiramate (100 or 200mg per day) compared with standard antiepileptic drugs (carbamazepine or valproate) in patients with newly diagnosed epilepsy. The study is composed of three phases: baseline (up to 7 days), double-blind treatment, and a blinded extension. The double-blind phase is divided into two periods: titration, in which the dose of drug is gradually increased (approximately 35 days), and stabilization (of variable duration, with regular scheduled visits up to 92 days and then every 3 months thereafter). The dose of study drug remains constant during the stabilization period. In the blinded extension, patients completing the double blind phase are given the opportunity to take the other study medication in a blinded fashion (patient unaware of identity of the drug). This phase continues until the patient leaves the study or the data base for the double blind phase is finalized. The primary assessment of effectiveness is the time to first seizure from Day 15 of the study. Safety assessments include the frequency of adverse events during the study, results of clinical laboratory tests (hematology and biochemistry), measurements of vital signs and body weight, and physical examination findings. The study hypothesis is that the 200mg dose of topiramate is superior to the 100mg dose in delaying the time to first seizure and is well-tolerated. Oral topiramate (25milligram [mg] or 50mg capsules or tablets),starting at 25mg/day (Week 1),increasing to 100mg or 200mg/day (Week 5).Increasing carbamazepine to 600mg/day or valproate to 1250mg/day (Week 5).Maximum dosages continue for a variable time and then taper over 4 weeks to starting dose.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body weight of at least 30 kilograms
  • New epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry
  • No history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks
  • Females must be sexually abstinent, surgically sterile, or using adequate birth control measures, and have a negative pregnancy test before study entry

Exclusion Criteria:

  • Patients who do not have epilepsy
  • Have progressive or degenerative disorders (for example, certain hereditary conditions)
  • Have a significant history (within last 2 years) of unstable medical diseases (heart, kidney, hormone, or liver diseases)
  • Have mental retardation or other condition that could make interpretation of the study results difficult
  • alcohol or drug abuse within the previous year
  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: NCT00236717

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: NCT00236717     History of Changes
Other Study ID Numbers: CR005461
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.:
Epilepsy
Seizures
Topiramate
Prophylaxis
Antiepileptic

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Topiramate
Valproic Acid
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 26, 2014