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Trial record 18 of 40 for:    CARBAMAZEPINE AND Valproic Acid

Population Pharmacokinetics of Antiepileptic in Pediatrics (EPIPOP)

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ClinicalTrials.gov Identifier: NCT03196466
Recruitment Status : Unknown
Verified December 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : June 22, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date June 20, 2017
First Posted Date June 22, 2017
Last Update Posted Date December 21, 2017
Actual Study Start Date June 19, 2017
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2017)
  • Volume of distribution [ Time Frame: through study completion, an average of 2 years ]
  • Absorption constant [ Time Frame: through study completion, an average of 2 years ]
  • Clearance [ Time Frame: through study completion, an average of 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03196466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 20, 2017)
Composite measure of the inter-individual variability [ Time Frame: through study completion, an average of 2 years ]
Covariates of inter-individual variability : age, weight, Co-treatments and renal function
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Population Pharmacokinetics of Antiepileptic in Pediatrics
Official Title Population Pharmacokinetics of Antiepileptic in Pediatrics
Brief Summary

The purpose of this study is to develop population pharmacokinetic models for antiepileptic drugs in a pediatric population.

The interest of these models is multiple:

  • describe the pharmacokinetics of these molecules in children and explain the inter-individual variability of concentrations through covariates such as weight, age, co-treatments and renal function;
  • estimate maximum, minimum and exposure concentrations from the individual pharmacokinetic parameters for each patient;
  • propose adaptations of doses for certain classes of children (according to age, weight etc.) and individualize the doses.
Detailed Description

Epilepsy affects about 1% of the population, with a peak incidence in childhood, and persistent seizures on antiepileptic therapy in approximately 30% of patients. Over the past two decades, many antiepileptic molecules have emerged, raising the question of their optimal use, especially in pediatrics, where pharmacokinetics and pharmacodynamics are different from adults and largely influenced by age and development.

The pharmacokinetics of antiepileptics have been little studied in pediatric populations. In children, it is important to know if a maturational effect (of age) has to be taken into account in addition to the physiological effect (of the weight) to adapt the doses. Moreover, these molecules are often used in combination and lot of enzyme interactions make their use delicate. All of these factors explain the existence of significant inter-individual variability in the pediatric population.

The implication of the demographic and medicinal factors mentioned above, as well as the balance of efficacy / undesirable effects, justify the interest of a pharmacological monitoring of these drugs in a pediatric population. The use of population pharmacokinetics is particularly interesting in children because it requires only a small number of samples per patient and can be used to describe the predominant inter-individual variability in this population.

The main goal is to develop population pharmacokinetic models for the following antiepileptic drugs in children: valproic acid, carbamazepine, phenobarbital, phenytoin, levetiracetam, lamotrigine, topiramate, oxcarbazepine, stiripentol and clobazam. The interest of these models is multiple:

  • describe the pharmacokinetics of these molecules in children and explain the interindividual variability of concentrations through covariates such as weight, age, co-treatments and renal function;
  • estimate maximum, minimum and exposure concentrations from the individual pharmacokinetic parameters for each patient;
  • propose adaptations of doses for certain classes of children (according to age, weight etc.) and individualize the doses.

The secondary objectives of this work are:

  • Build models jointly with several antiepileptic drugs, accounting for the strength of interactions between them during multiple therapies.
  • Link antiepileptic concentrations to the effects of treatment (reduction or cessation of seizures): pharmacokinetic-pharmacodynamic study with concentration / efficacy and concentration / toxicity relationships.
  • The evaluation of preexisting models in the literature and the comparison of the data with the results of these models (external validation).

Pharmaco-statistical analysis will be carried out on the retrospective data of patients treated with one or more antiepileptic molecule (s) and whose blood dosage of the drug(s) as part of their therapeutic follow-up is available

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Minor patient treated by one or more antiepileptics and for which a blood test has been performed
Condition Epilepsy
Intervention
  • Biological: Valproic acid
    titration
  • Biological: carbamazepine
    titration
  • Biological: phenobarbital
    titration
  • Biological: phenytoin
    titration
  • Biological: levetiracetam
    titration
  • Biological: lamotrigine
    titration
  • Biological: topiramate
    titration
  • Biological: oxcarbazepine
    titration
  • Biological: stiripentol
    titration
  • Biological: clobazam
    titration
Study Groups/Cohorts antiepileptics titration
Titration of valproic acid, carbamazepine, phenobarbital, phenytoin, levetiracetam, lamotrigine, topiramate, oxcarbazepine, stiripentol and clobazam
Interventions:
  • Biological: Valproic acid
  • Biological: carbamazepine
  • Biological: phenobarbital
  • Biological: phenytoin
  • Biological: levetiracetam
  • Biological: lamotrigine
  • Biological: topiramate
  • Biological: oxcarbazepine
  • Biological: stiripentol
  • Biological: clobazam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 20, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children from 0 to 18 years of age with epilepsy;
  • Treatment with one or more antiepileptic drug (s) studied (valproic acid, carbamazepine, phenobarbital, phenytoin, levetiracetam, lamotrigine, topiramate, oxcarbazepine, stiripentol and clobazam);
  • Blood dosage of the drug (s) as part of their therapeutic follow-up in the Pharmacology laboratory of the Cochin hospital between 2007 and 2017

Exclusion Criteria:

  • patient with missing data on time of last drug taking, time of collection, co-treatments and / or dose administered;
  • patient with doubt about compliance
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03196466
Other Study ID Numbers NI17009HLJ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Jean-Marc TRELUYER, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2017