EpilepsyNCT01218321
The Effect of Anti-epileptic Drugs on Mitochondrial Activity
An observational study of Epilepsy, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- antiepileptic treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children, ages 3 to 18 years old who start new antiepileptic drug treatment for the first time for new onset epilepsy
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- antiepileptic treatment
- Keywords
- antiepileptic drugs, mitochondria
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiepileptic treatmentBiological
Also called study group
White blood cells from peripheral blood samples
| Study group | Role | What they receive |
|---|---|---|
| Antiepileptic treatment group | Group of patients treated by antiepileptic medications Receives: Biological: antiepileptic treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Itai Berger, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218321
- Sponsor's protocol ID
- 0582-09-HMO-CTIL
- Status last verified
- Oct 2010
- First submitted
- 7 Oct 2010
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berger I, Segal I, Shmueli D, Saada A. The effect of antiepileptic drugs on mitochondrial activity: a pilot study. J Child Neurol. 2010 May;25(5):541-5. doi: 10.1177/0883073809352888.
PubMed 20413803
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study for Measuring the Effect of Antiepileptic Drugs on Mitochondrial Activity
- ClinicalTrials.gov ID
- NCT01218321
- Acronym / sponsor ID
- 0582-09-HMO-CTIL
- Conditions
- Epilepsy
- Keywords
- antiepileptic drugs, mitochondria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antiepileptic treatment group | – | Biological: antiepileptic treatmentGroup of patients treated by antiepileptic medications |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children, ages 3 to 18 years old who start new antiepileptic drug treatment for the first time for new onset epilepsy
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiepileptic treatmentAlso: study groupWhite blood cells from peripheral blood samples | Biological | Antiepileptic treatment group |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Background: PubMed 20413803Berger I, Segal I, Shmueli D, Saada A. The effect of antiepileptic drugs on mitochondrial activity: a pilot study. J Child Neurol. 2010 May;25(5):541-5. doi: 10.1177/0883073809352888.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itai Berger, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01218321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.