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Completed

NCT Number: NCT00419393

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aguascalientes, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Keppra XR (Levetiracetam XR)

Drug

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

Other names: Keppra XR

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 8, 2007
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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