The Effect of Anti-epileptic Drugs on Mitochondrial Activity

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Completed
CT.gov ID
NCT01218321
Collaborator
(none)
60
1
17
3.5

Study Details

Study Description

Brief Summary

This study is based on the hypothesis that antiepileptic drugs (other than Valproic acid) have an effect on the mitochondrial oxidative phosphorylation.

The objective of this study is to evaluate this effect in an accessible tissue-human peripheral white blood cells.

Condition or Disease Intervention/Treatment Phase
  • Biological: antiepileptic treatment

Detailed Description

Antiepileptic drugs adverse reactions, including hepatotoxicity, are rare but potentially fatal, especially among children. Although the mechanism of the liver toxicity remains elusive, mitochondrial oxidative stress, has been hypothesized to play a role.

Most of the studies addressing antiepileptic drug effects on the mitochondria discuss the effect of valproic acid. The exact mechanisms involved in the drug-induced effects on oxidative phosphorylation are still far from being resolved. Most of the studies investigated the effect of valproic acid by using animal models or different in vitro methods.Mitochondrial diseases should be considered as a risk factor for valproic acid-induced hepatotoxicity, and there is a consensus for avoiding the administration of the drug for these patientsIs it possible that other antiepileptic drugs have similar effects? The knowledge regarding the effects of other antiepileptic drugs on the mitochondria is relatively scarce.

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Phase 1 Study for Measuring the Effect of Antiepileptic Drugs on Mitochondrial Activity
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Antiepileptic treatment group

Group of patients treated by antiepileptic medications

Biological: antiepileptic treatment
White blood cells from peripheral blood samples
Other Names:
  • study group
  • Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      3 Years to 18 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Children between the ages of 3 and 18 years old, who suffer from new onset epilepsy as diagnosed by a certified pediatric neurologist, who do not suffer from a ''metabolic'' disorder, are treated by a single antiepileptic drug, and are not receiving any other type of medication on a chronic basis were included
      Exclusion Criteria:
      • Children younger than 3 years of age or older than 18 years of age, children who were suspected or known to suffer from a ''metabolic'' disorder or liver dysfunction, children who were under treatment, by any medication on a chronic basis, at the time of the study were excluded.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hadassah-Hebrew University Medical Center Jerusalem Israel 91240

      Sponsors and Collaborators

      • Hadassah Medical Organization

      Investigators

      • Principal Investigator: Itai Berger, MD, Hadassah Medical Organization

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Hadassah Medical Organization
      ClinicalTrials.gov Identifier:
      NCT01218321
      Other Study ID Numbers:
      • 0582-09-HMO-CTIL
      First Posted:
      Oct 11, 2010
      Last Update Posted:
      Mar 6, 2018
      Last Verified:
      Oct 1, 2010
      Keywords provided by Hadassah Medical Organization
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Mar 6, 2018