- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00150748
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
Status
Completed
Conditions
Intervention / Treatment
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.).
|
|
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N167
- 2004-001997-13 (EudraCT Number)
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.
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