Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures

NCT00152516 | Completed Phase 3 Results

• 2 other identifiers: N01148EudraCT number:2004-000200-40
• Study Type: interventional
• Target: 255
• Locations: 16 countries
• Sites: 84

Brief Summary

To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

Conditions

Epilepsy, Partial

Keywords

Partial Onset Seizures; levetiracetam; Epilepsy; Keppra

Outcome Measures

Primary Outcomes (1)

• Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.

  Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.

  Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Secondary Outcomes (20)

• Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.

  Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

• Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.

  Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

• Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.

  Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

• Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period

  Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

• Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period

  Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Study Arms (1)

Levetiracetam

EXPERIMENTAL

Drug: levetiracetam (LEV)

Interventions

levetiracetam (LEV) DRUG

Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.

Also known as: Keppra

Levetiracetam

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit

You may not qualify if:

• Patients on a ketogenic diet
• Seizures too close together to accurately count
• Pseudoseizures
• Status epilepticus 1 month prior Visit 1
• Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (84)

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Los Angeles, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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Loxahatchee Groves, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Saint Paul, Minnesota, United States

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Lebanon, New Hampshire, United States

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Edison, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Buffalo, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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Chapel Hill, North Carolina, United States

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Cleveland, Ohio, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Fort Worth, Texas, United States

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Galveston, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Brussels, Belgium

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Leuven, Belgium

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Campinas, Brazil

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Curitiba, Brazil

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Vancouver, British Columbia, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Brno, Czechia

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Prague, Czechia

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Lille, France

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Paris, France

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Strasbourg, France

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Kehl, Kork, Germany

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Berlin, Germany

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Erlangen, Germany

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Heidelberg, Germany

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Jena, Germany

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Kiel, Germany

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Budapest, Hungary

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Hyderabad, India

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Lucknow, India

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Mahim Mumbai, India

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Mumbai, India

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Pune Maharashtra, India

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Calambrone, Italy

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Genoa, Italy

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Milan, Italy

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Roma, Italy

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Mexico City, Mexico

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Gdansk, Poland

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Bucharest, Romania

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Cluj-Napoca, Romania

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Târgu Mureş, Romania

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Kalingrad, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Cape Town, South Africa

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Capitol Park, South Africa

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Johannesburg, South Africa

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Bristol, United Kingdom

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Cardiff, United Kingdom

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London, United Kingdom

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Related Publications (1)

• Pina-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017.

  PMID: 21095488 RESULT

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB Pharma

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: October 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 12, 2013
• Results First Posted: January 13, 2010

Record last verified: 2010-04

Locations

BE (2); DE (6); ZA (3); US (38); HU (1); ME (1); BR (6); RO (3); IN (5); RU (3); GB (3); CA (3); FR (3); IT (4); PL (1); CZ (2)