Conversion to Monotherapy Study With Keppra XR for Partial Seizures

Epilepsy Clinical Trial

Official title:

A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419094
• Other study ID #: N01280
• Secondary ID: 2007-000897-21
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2007
• Last updated: August 26, 2014
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: January 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: Ministry of HealthPoland: Ministry of HealthRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female subjects 12 to 75 years of age.

• Subjects must have inadequately controlled partial onset epilepsy.

• Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)

Exclusion Criteria:

• A history of status epilepticus in the 6 months preceding randomization.

• Significant medical, psychiatric or neurological illness.

• Intake of benzodiazepines on more than an occasional basis

• History of previous treatment with levetiracetam or sensitivity to levetiracetam.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Keppra XR
Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
• Keppra XR
Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Mexico,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase	Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.	112 days	No
Secondary	The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase	The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112.	112 days	No
Secondary	The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase	The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112.	112 days	No
Secondary	The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase	Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112.	112 days	No

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