Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
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.). |
Drug: Levetiracetam 166 mg
Active Substance: Levetiracetam
Pharmaceutical Form: Tablet
Concentration: 166 mg
Route of Administration: Oral use
Drug: Levetiracetam 250 mg
Active Substance: Levetiracetam
Pharmaceutical Form: Tablet
Concentration: 250 mg
Route of Administration: Oral use
Drug: Levetiracetam 500 mg
Active Substance: Levetiracetam
Pharmaceutical Form: Tablet
Concentration: 500 mg
Route of Administration: Oral use
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
- 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 [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 [Evaluation Period]
- Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types [Evaluation Period]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV)
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Subjects who were/are suffering from primary generalized (type II) epileptic seizures
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Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected
Exclusion Criteria:
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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
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Concomitant use of any drug with possible central nervous system effects unless at a stable dose
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- UCB Pharma SA
Investigators
- Study Director: UCB Clinical Trial Call Center, +1 877-822-9493
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- N167
- 2004-001997-13