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

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

Genetics Home Reference related topics:

pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics:

Epilepsy

Drug Information available for:

Divalproex sodium Valproate Sodium Valproic acid

U.S. FDA Resources

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.

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 ]

Estimated Enrollment:	80
Study Start Date:	March 2006
Estimated Primary Completion Date:	October 2009 (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

Responsible Party:	sanofi-aventis ( "Medical Affairs Study Director" )
Study ID Numbers:	L-8971, EudraCT #: 2005-004041-33
First Received:	October 6, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00385411
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Epilepsy

Central Nervous System Diseases

Brain Diseases

Valproic Acid

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 Depressants

Enzyme Inhibitors

Antimanic Agents

Pharmacologic Actions

Therapeutic Uses

GABA Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on October 29, 2008

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