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Study of Valproate in Young Patients Suffering From Epilepsy (VAPOP)

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ClinicalTrials.gov Identifier: NCT00385411
Recruitment Status : Completed
First Posted : October 9, 2006
Last Update Posted : October 6, 2009
Sponsor:
Information provided by:
Sanofi

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: valproate microgranules Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: valproate Drug: valproate microgranules
20 to 30 mg/kg/day




Primary Outcome Measures :
  1. Clinical and biological safety. [ Time Frame: at each visit ]
  2. Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate [ Time Frame: Ancillary population kinetics study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385411


Locations
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France
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Marie SEBILLE, Dr Sanofi

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Responsible Party: "Medical Affairs Study Director", sanofi-aventis
ClinicalTrials.gov Identifier: NCT00385411     History of Changes
Other Study ID Numbers: L_8971
EudraCT #: 2005-004041-33
First Posted: October 9, 2006    Key Record Dates
Last Update Posted: October 6, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs