Study of Valproate in Young Patients Suffering From Epilepsy - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00385411

Purpose

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	Intervention	Phase
Epilepsy	Drug: valproate microgranules	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Divalproex sodium Valproic acid Valproate Sodium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Clinical and biological safety. [ Time Frame: at each visit ] [ Designated as safety issue: Yes ]
Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate [ Time Frame: Ancillary population kinetics study ] [ Designated as safety issue: No ]

Enrollment:	82
Study Start Date:	March 2006
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
valproate: Experimental	Drug: valproate microgranules 20 to 30 mg/kg/day

Eligibility

Ages Eligible for Study:	6 Months to 15 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385411

Locations

France
Sanofi-aventis
Paris, France

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Marie SEBILLE, Dr

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( "Medical Affairs Study Director" )
Study ID Numbers:	L_8971, EudraCT #: 2005-004041-33
Study First Received:	October 6, 2006
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00385411 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Epilepsy
Psychotropic Drugs
Central Nervous System Depressants

Central Nervous System Diseases
Antimanic Agents
Brain Diseases
Valproic Acid
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Diseases
Central Nervous System Depressants
Enzyme Inhibitors

Brain Diseases
Antimanic Agents
Valproic Acid
Pharmacologic Actions
Epilepsy
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 03, 2009