A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Epilepsy.

NCT00236847 | Completed Phase 2

• 1 other identifier: CR005566
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of topiramate as an add-on therapy in patients with uncontrolled partial onset seizures who are taking one or two standard antiepileptic drugs.

Conditions

Epilepsy; Epilepsies, Partial; Seizures

Keywords

topiramate; epilepsy; partial epilepsy; seizures; epileptic seizures; partial seizure disorder; brain diseases

Outcome Measures

Primary Outcomes (1)

• Percent reduction in the average monthly seizure rate from baseline to end of treatment

Secondary Outcomes (1)

• Percent of patients responding to treatment (>= 50% reduction in seizure rate from baseline to end of treatment); patient's and investigator's global assessments at end of study; incidence of adverse events throughout study

Interventions

topiramate DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• females who are pregnant, nursing, or those not using adequate birth control if capable of having children

Sponsors & Collaborators

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

Related Publications (1)

• Tassinari CA, Michelucci R, Chauvel P, Chodkiewicz J, Shorvon S, Henriksen O, Dam M, Reife R, Pledger G, Karim R. Double-blind, placebo-controlled trial of topiramate (600 mg daily) for the treatment of refractory partial epilepsy. Epilepsia. 1996 Aug;37(8):763-8. doi: 10.1111/j.1528-1157.1996.tb00649.x.

  PMID: 8764816 RESULT

Related Links

• A study of the efficacy and safety of topiramate in the treatment of patients with epilepsy

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial; Seizures; Brain Diseases

Interventions

Topiramate

Condition Hierarchy (Ancestors)

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 2
• 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, 1989
• Study Completion: July 1, 1993
• Last Updated: June 8, 2011

Record last verified: 2010-04