Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

Epilepsy Clinical Trial

Official title:

An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419393
• Other study ID #: N01281
• Secondary ID: 2007-000899-17
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2007
• Last updated: August 26, 2014
• Start date: December 2007
• Est. completion date: March 2010

Study information

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

Clinical Trial Summary

To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period

Exclusion Criteria:

• Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]

• Subjects who were discontinued prior to the end of titration period

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Keppra XR (Levetiracetam XR)
500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).

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	Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)	An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Duration of the Treatment Period (6 months-2 years)	No
Primary	Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)	A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.	Duration of the Treatment Period (6 months-2 years)	No
Primary	Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period	An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Duration of the Treatment Period (6 months-2 years)	No
Secondary	Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months	Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.	Study entry through 6 months	No
Secondary	Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months	Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.	Study entry through 12 months	No

External Links

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