A Comparison of the Effectiveness and Safety of Topiramate and Phenytoin in Patients With New Onset Epilepsy Requiring Rapid Initiation of Antiepileptic Drug Treatment

NCT00210782 | Completed Phase 3

• 1 other identifier: CR004663
• Study Type: interventional
• Target: 262
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effectiveness and safety of two treatment regimens, topiramate as compared to phenytoin, in preventing seizures in patients with new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug to an effective dose, may include severe or frequent seizures, or high risk to the patient of recurrent seizures.

Conditions

Epilepsy

Keywords

epilepsy; seizures; epileptic seizures; complex partial seizures; generalized tonic-clonic seizures

Outcome Measures

Primary Outcomes (1)

• The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.

Secondary Outcomes (1)

• Effect of sex, age, baseline weight, baseline seizure type, and duration since first diagnosis of epilepsy on the time to seizure.

Interventions

topiramate, phenytoin DRUG

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Seizures indicative of new-onset epilepsy (or epilepsy relapse) of untreated epilepsy
• at least one but not more than 20 unprovoked seizures within past 3 months
• weighing more than 110 pounds
• considered to be a good candidate for rapid initiation of anti-seizure medication
• able to swallow a tablet whole (without crushing it).

You may not qualify if:

• Not having taken anti-seizure medications within the past 30 days
• no provoking factors for seizures (presence of alcohol withdrawal, drug intoxication, acute meningitis or encephalitis, acute head injury or stroke, acute hypoxic/ischemic encephalopathy, or brain tumor)
• no presence of active liver disease or serious kidney disease
• not pregnant or breast-feeding
• not using birth control.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho-McNeil Neurologics, Inc.: collaborator

Related Publications (1)

• Ramsay E, Faught E, Krumholz A, Naritoku D, Privitera M, Schwarzman L, Mao L, Wiegand F, Hulihan J; CAPSS-272 Study Group. Efficacy, tolerability, and safety of rapid initiation of topiramate versus phenytoin in patients with new-onset epilepsy: a randomized double-blind clinical trial. Epilepsia. 2010 Oct;51(10):1970-7. doi: 10.1111/j.1528-1167.2010.02670.x.

  PMID: 20633037 DERIVED

Related Links

• Topiramate vs. Phenytoin in New Onset Epilepsy

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Topiramate; Phenytoin

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; Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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 13, 2005
• First Posted: September 21, 2005
• Study Start: June 1, 2004
• Study Completion: August 1, 2007
• Last Updated: June 10, 2011

Record last verified: 2010-03