A Study of the Efficacy and Safety of Topiramate in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures

NCT00236418 | Completed Phase 3

• 1 other identifier: CR005830
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of topiramate as an add-on therapy in epilepsy patients with uncontrolled primary generalized tonic-clonic seizures, who are taking 1 or 2 standard antiepileptic drugs.

Conditions

Epilepsy; Seizures

Keywords

Epilepsy; Seizures; Topiramate; Prophylaxis; Antiepileptic; Tonic-clonic seizures; Grand mal seizures

Outcome Measures

Primary Outcomes (1)

• Percent reduction from baseline in primary generalized tonic-clonic seizure rates and percent responders (>=50% reduction in PGTC seizure rate from baseline), during the double-blind phase. Subjects' global evaluation of improvement in seizure severity.

Secondary Outcomes (1)

• Percent reduction from baseline of all seizure types and percent of treatment responders in all seizure types, during the double-blind phase. Safety evaluations conducted throughout the study.

Interventions

topiramate DRUG

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Body weight \>25 kilograms (55 pounds)
• diagnosis of primary generalized epilepsy
• must have primary generalized tonic-clonic (PGTC) seizures treated with 1 or 2 antiepileptic drugs
• must have three PGTC seizures during baseline period, with at least 1 during each 28-day period of baseline
• females must not have had their first menstrual period or be postmenopausal, or are physically incapable of child bearing, or if of child bearing potential, sexually abstinent, or using adequate birth control measures, and have a negative pregnancy test before study entry.

You may not qualify if:

• Patients who do not have epilepsy, such as those with a treatable cause of seizure (for example, active infection or cancer)
• patients with progressive disorders (for example, active infection, cancer or metabolic disturbance)
• patients diagnosed with Lennox-Gastaut syndrome
• history of seizures occurring in only cluster patterns (numerous seizures occurring over a short period of time \[\<30 minutes\])
• documented history (previous 3 months) of generalized tonic-clonic status epilepticus (status epilepticus is a prolonged seizure or seizures repeated frequently over 20 to 30 minutes so that recovery between episodes does not occur) while receiving appropriate antiepileptic medication.

Sponsors & Collaborators

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

Related Publications (1)

• Montouris GD, Biton V, Rosenfeld WE. Nonfocal generalized tonic-clonic seizures: response during long-term topiramate treatment. Topiramate YTC/YTCE Study Group. Epilepsia. 2000;41(S1):77-81. doi: 10.1111/j.1528-1157.2000.tb02177.x.

  PMID: 10768306 RESULT

Related Links

• A study of the efficacy and safety of topiramate in patients with primary generalized tonic-clonic seizures

MeSH Terms

Conditions

Epilepsy; Seizures; Epilepsy, Tonic-Clonic

Interventions

Topiramate

Condition Hierarchy (Ancestors)

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

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: October 7, 2005
• First Posted: October 12, 2005
• Study Start: December 1, 1994
• Study Completion: December 1, 1996
• Last Updated: June 8, 2011

Record last verified: 2010-04