Back to resultsA Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures
Primary Purpose
Absence Seizures
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Absence Seizures focused on measuring Levetiracetam, Keppra
Eligibility Criteria
Inclusion Criteria:
- Male/female 4-17 years old having participated in study N162 or in study N163
- suffering from typical absences with 3 Hz spike-wave discharges, with or without tonic-clonic seizures, in CAE or JAE
- expected reasonable benefit (efficacy and tolerability) of levetiracetam long term administration
Exclusion Criteria:
- allergy/intolerance to pyrrolidine derivatives and/or excipients
- use of > 2 concomitant antiepileptic treatment or valproate, ethosuximide or lamotrigine
Sites / Locations
Outcomes
Primary Outcome Measures
Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00545012
Brief Title
A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures
Official Title
A 30-month Safety and Efficacy Follow-up Study With Levetiracetam at Individualized Optimal Dose in Children (4-17 Years Old at Inclusion) Suffering From Typical Absences in Childhood Absence Epilepsy (CAE) or Juvenile Absence Epilepsy (JAE)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This long-term open label follow-up trial gave pediatric subjects suffering from typical absences in CAE or JAE the opportunity to continue levetiracetam treatment after participation in the pilot study (study N162) or the double-blind study (study N163). Safety and efficacy data were obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Absence Seizures
Keywords
Levetiracetam, Keppra
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Primary Outcome Measure Information:
Title
Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male/female 4-17 years old having participated in study N162 or in study N163
suffering from typical absences with 3 Hz spike-wave discharges, with or without tonic-clonic seizures, in CAE or JAE
expected reasonable benefit (efficacy and tolerability) of levetiracetam long term administration
Exclusion Criteria:
allergy/intolerance to pyrrolidine derivatives and/or excipients
use of > 2 concomitant antiepileptic treatment or valproate, ethosuximide or lamotrigine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures
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