Clinical trial NCT00150748: Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Epilepsy
Keywords: Generalized Epilepsy, Primary Generalized Seizures
Keppra, Levetiracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 217
Sex: ALL
Minimum age (years): 4
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
timeFrame: Evaluation Period
measure: Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
timeFrame: Evaluation Period
Secondary outcomes:
measure: 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
timeFrame: From Visit 1 to the end of the Evaluation Period
measure: 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
timeFrame: From Visit 1 to the end of the Evaluation Period
measure: Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
timeFrame: From N01057 or N166 Baseline to the Evaluation Period
measure: Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
timeFrame: From N01057 or N166 Baseline to the Evaluation Period
measure: Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
timeFrame: From N01057 or N166 Baseline to the Evaluation Period
measure: 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
timeFrame: From N01057 or N166 Baseline to the Evaluation Period
measure: Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
timeFrame: Evaluation Period
measure: Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
timeFrame: Evaluation Period
Other outcomes:
Locations:
Study officials:
affiliation: +1 877-822-9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.