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

NCT00230698 | Completed Phase 3

• 1 other identifier: CR002503
• Study Type: interventional
• Target: 451
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Epilepsy; Epilepsies, Partial; Seizures

Keywords

Epilepsy; Partial Epilepsies; Seizures; Topiramate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Laboratory, vital signs, electrocardiogram data and adverse events reported during the trial.

Interventions

topiramate DRUG

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• Gilliam FG, Veloso F, Bomhof MA, Gazda SK, Biton V, Ter Bruggen JP, Neto W, Bailey C, Pledger G, Wu SC. A dose-comparison trial of topiramate as monotherapy in recently diagnosed partial epilepsy. Neurology. 2003 Jan 28;60(2):196-202. doi: 10.1212/01.wnl.0000048200.12663.bc.

  PMID: 12552030 RESULT

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial; Seizures

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 29, 2005
• First Posted: October 3, 2005
• Study Start: November 1, 1995
• Study Completion: August 1, 2002
• Last Updated: November 15, 2010

Record last verified: 2010-11