NCT00385411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 6, 2009

Status Verified

October 1, 2009

Enrollment Period

2.6 years

First QC Date

October 6, 2006

Last Update Submit

October 2, 2009

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

  • Clinical and biological safety.

    at each visit

  • Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate

    Ancillary population kinetics study

Study Arms (1)

valproate

EXPERIMENTAL
Drug: valproate microgranules

Interventions

valproate microgranulesDRUG

20 to 30 mg/kg/day

valproate

Eligibility Criteria

Age6 Months - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 6 months and 15 years.
  • Suffering from any type of epilepsy.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Paris, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Marie SEBILLE, Dr

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 6, 2006

First Posted

October 9, 2006

Study Start

March 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 6, 2009

Record last verified: 2009-10

Locations

FR(1)