Back to resultsStudy of Valproate in Young Patients Suffering From Epilepsy (VAPOP)
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
valproate microgranules
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Children aged between 6 months and 15 years.
- Suffering from any type of epilepsy.
- Receiving at the time of inclusion valproate in the form Micropakine® SR 20 to 30 mg/kg/d by oral route, in 2 daily administrations and at most two other antiepileptic drugs (an antiepileptic benzodiazepine treatment taken daily or on demand more than 2 times weekly, must be considered as an antiepileptic treatment).
- Followed by hospital paediatricians or neuropaediatricians.
- For whom the consent has been signed by the parents or the holders of parental authority and if possible by the child him/herself.
- For whom the parents or legal guardian do not have any language or cultural obstacle for understanding the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
valproate
Arm Description
Outcomes
Primary Outcome Measures
Clinical and biological safety.
Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00385411
Brief Title
Study of Valproate in Young Patients Suffering From Epilepsy
Acronym
VAPOP
Official Title
Therapeutic Follow-up Observational Study and Population Kinetics Ancillary Study of Valproate Microgranules (Micropakine® SR) in Patients Aged Between 6 Months and 15 Years Suffering From Epilepsy.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays.
Secondary objectives: Ancillary population kinetics study
Estimate the pharmacokinetic parameters of valproate administered as microgranules under standard therapeutic conditions within the population studied, from the therapeutic follow-up data.
Evaluate the influence of individual characteristics on the pharmacokinetic parameters.
Describe the relationship between plasma concentrations and adverse events for valproate and the main anti-epileptic comedications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
valproate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
valproate microgranules
Intervention Description
20 to 30 mg/kg/day
Primary Outcome Measure Information:
Title
Clinical and biological safety.
Time Frame
at each visit
Title
Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate
Time Frame
Ancillary population kinetics study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged between 6 months and 15 years.
Suffering from any type of epilepsy.
Receiving at the time of inclusion valproate in the form Micropakine® SR 20 to 30 mg/kg/d by oral route, in 2 daily administrations and at most two other antiepileptic drugs (an antiepileptic benzodiazepine treatment taken daily or on demand more than 2 times weekly, must be considered as an antiepileptic treatment).
Followed by hospital paediatricians or neuropaediatricians.
For whom the consent has been signed by the parents or the holders of parental authority and if possible by the child him/herself.
For whom the parents or legal guardian do not have any language or cultural obstacle for understanding the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie SEBILLE, Dr
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Valproate in Young Patients Suffering From Epilepsy
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