The Effect of Anti-epileptic Drugs on Mitochondrial Activity

March 4, 2018 updated by: Hadassah Medical Organization

Phase 1 Study for Measuring the Effect of Antiepileptic Drugs on Mitochondrial Activity

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91240
        • Hadassah-Hebrew University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children, ages 3 to 18 years old who start new antiepileptic drug treatment for the first time for new onset epilepsy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 4, 2018

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0582-09-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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