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

July 28, 2020 updated by: UCB Pharma SA

An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/Day (or 80 mg/kg/Day for Children and Adolescents Less Than 50 kg), in Children (≥ 4 Years Old), Adolescents and Adults Suffering From Primary Generalized Seizures

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levetiracetam
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.).
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 166 mg
  • Route of Administration: Oral use
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 250 mg
  • Route of Administration: Oral use
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 500 mg
  • Route of Administration: Oral use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
Time Frame: Evaluation Period
Evaluation Period
Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
Time Frame: Evaluation Period
Evaluation Period

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: From Visit 1 to the end of 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
Time Frame: From Visit 1 to the end of 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
Time Frame: From N01057 or N166 Baseline to the Evaluation Period
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
Time Frame: From N01057 or N166 Baseline to the Evaluation Period
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
Time Frame: From N01057 or N166 Baseline to the Evaluation Period
From N01057 or N166 Baseline to the Evaluation Period
Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
Time Frame: From N01057 or N166 Baseline to the Evaluation Period
From N01057 or N166 Baseline to the Evaluation Period
Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
Time Frame: Evaluation Period
Evaluation Period
Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
Time Frame: Evaluation Period
Evaluation Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: UCB Clinical Trial Call Center, +1 877-822-9493

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Generalized Epilepsy

Clinical Trials on Levetiracetam 166 mg

3
Subscribe