Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

NCT00150748 | Completed Phase 3

• 2 other identifiers: N1672004-001997-13
• Study Type: interventional
• Target: 217
• Locations: 0 countries
• Sites: N/A

Brief Summary

An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.

Conditions

Generalized Epilepsy

Keywords

Generalized Epilepsy, Primary Generalized Seizures; Keppra, Levetiracetam

Outcome Measures

Primary Outcomes (2)

• Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

  Evaluation Period

• Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

  Evaluation Period

Secondary Outcomes (8)

• Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period

  From Visit 1 to the end of the Evaluation Period

• Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period

  From Visit 1 to the end of the Evaluation Period

• Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

  From N01057 or N166 Baseline to the Evaluation Period

• Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

  From N01057 or N166 Baseline to the Evaluation Period

• Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

  From N01057 or N166 Baseline to the Evaluation Period

Study Arms (1)

Levetiracetam

EXPERIMENTAL

Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).

Drug: Levetiracetam 166 mg; Drug: Levetiracetam 250 mg; Drug: Levetiracetam 500 mg

Interventions

Levetiracetam 166 mg DRUG

* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 166 mg * Route of Administration: Oral use

Levetiracetam

Levetiracetam 250 mg DRUG

* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 250 mg * Route of Administration: Oral use

Levetiracetam

Levetiracetam 500 mg DRUG

* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 500 mg * Route of Administration: Oral use

Levetiracetam

Eligibility Criteria

• Age: 4 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV)
• Subjects who were/are suffering from primary generalized (type II) epileptic seizures
• Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected

You may not qualify if:

• Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol
• Concomitant use of any drug with possible central nervous system effects unless at a stable dose
• Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time

Sponsors & Collaborators

• UCB Pharma SA: lead

Related Publications (1)

• Delanty N, Jones J, Tonner F. Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: open-label, noncomparative, multicenter, long-term follow-up study. Epilepsia. 2012 Jan;53(1):111-9. doi: 10.1111/j.1528-1167.2011.03300.x. Epub 2011 Nov 2.

  PMID: 22050371 DERIVED

MeSH Terms

Conditions

Epilepsy, Generalized

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Epilepsy; 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

Study Officials

• UCB Clinical Trial Call Center

  +1 877-822-9493

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: November 1, 2001
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: July 29, 2020

Record last verified: 2020-07