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Trial record 1 of 1 for:    NCT00419393
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Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

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ClinicalTrials.gov Identifier: NCT00419393
Recruitment Status : Completed
First Posted : January 8, 2007
Results First Posted : July 13, 2011
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Keppra XR (Levetiracetam XR) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures
Study Start Date : December 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arms and Interventions
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Arm Intervention/treatment
Experimental: Keppra XR (Levetiracetam XR)
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
 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).
Other Name: Keppra XR


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) [ Time Frame: Duration of the 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.

  2. Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) [ Time Frame: Duration of the 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.

  3. Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period [ Time Frame: Duration of the 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.


Secondary Outcome Measures :
  1. Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months [ Time Frame: 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.

  2. Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419393


Locations
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United States, Alabama
Dothan, Alabama, United States
Northport, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Bakersfield, California, United States
United States, Florida
Loxahatchee, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Suwanee, Georgia, United States
United States, Kansas
Witchita, Kansas, United States
United States, Michigan
Detroit, Michigan, United States
United States, New Jersey
Camden, New Jersey, United States
United States, New York
Buffalo, New York, United States
Cedarhurst, New York, United States
United States, Ohio
Toledo, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Texas
San Antonio, Texas, United States
Mexico
Aguascalientes, Mexico
Guadalajara Jalisco, Mexico
Guadalajara, Mexico
Mexico City, Mexico
Mexico DF, Mexico
Monterrey, Mexico
Poland
Bialystok, Poland
Gdansk, Poland
Katowice, Poland
Lodz, Poland
Lublin, Poland
Poznan, Poland
Szczecin, Poland
Warszawa, Poland
Russian Federation
Kalingrad, Russian Federation
Kazan, Russian Federation
Moscow, Russian Federation
Samara, Russian Federation
St Petersburg, Russian Federation
St. Petersburg, Russian Federation
Yaroslavl, Russian Federation
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center, MD +1 877 822 9493 (UCB)
More Information
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Additional Information:

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00419393    
Other Study ID Numbers: N01281
2007-000899-17 ( EudraCT Number )
First Posted: January 8, 2007    Key Record Dates
Results First Posted: July 13, 2011
Last Update Posted: September 5, 2014
Last Verified: June 2011
Keywords provided by UCB Pharma:
Keppra XR
Levetiracetam XR
long term
partial seizures
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations
 Levetiracetam
Anticonvulsants
Nootropic Agents