EpilepsyNCT00460070
Study of Hormonal Sideeffects in Patients Taking Levetiracetam, Carbamazepine or Lamotrigine for Epilepsy
An observational study of Epilepsy, run by Rikshospitalet University Hospital at 1 site in Norway.
Trial summary
Some antiepileptic drugs are found to have hormonal side effects. We want to study possible hormonal side effects of the relatively new antiepileptic drug; levetiracetam and compare it to the older drugs; lamotrigine and carbamazepine. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- How many people
- 240 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to Mar 2009
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients from the outpatients clinic
Who may be able to join
- Having epilepsy
- Age 18- 45
- Using levetiracetam/ lamotrigine or carbamazepine in monotherapy for at least 6 months
Who cannot join
- Hormonal diseases( ie; diabetes, hypo/ hyperthyroid disease)
- Use of hormonal anticonception drugs or other hormonal drugs.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dep. of Neurology, Rikshospitalet Universty Hospital
Oslo, Oslo, 0027
About this study
Official title: Levetiracetam, Carbamazepine and Lamotrigine and Hormonal Side Effects in Adult Males and Females.
Some antiepileptic drugs are found to have hormonal side effects. We want to study possible hormonal side effects of the relatively new antiepileptic drug; levetiracetam and compare it to the older drugs; lamotrigine and carbamazepine. The participants are going to fill in a questionnaire and we will collect blood samples from them, to analyse hormones.
Read the detailed description
We have previously performed long-term studies of rats treated with levetiracetam and compared them with a control group. Here we have found that levetiracetam has a probable effect on the ovaries, since the treated animals had larger ovaries, fewer cysts, more corpora lutea and more secondary follicles than the untreated animals (Taubøll et al 2004). Blood tests on the animals showed that those treated with levetiracetam had higher testosterone levels and lower levels of estrogen and FSH, whilst LH and progesterone levels were unaffected by the treatment (Svalheim et al, 2005a, b). Studies on cell cultures from pig ovaries, as carried out by our group in collaboration with Jagiellonian University, Krakow, Poland, appeared to support these findings (Taubøll et al. 2006, submitted).
Our wish therefore now is to study fertile men and women in order to look for any changes in the balance of sex hormones during use of levetiracetam in order to establish whether the findings in animal trials are clinically relevant to humans.
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startJan 2007
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rikshospitalet University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Erik Taubøll, MD, Principal investigator, unaffiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460070
- Sponsor's protocol ID
- M52332
- Status last verified
- Oct 2009
- First submitted
- 12 Apr 2007
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bachmann T, Bertheussen KH, Svalheim S, Rauchenzauner M, Luef G, Gjerstad L, Tauboll E. Haematological side effects of antiepileptic drug treatment in patients with epilepsy. Acta Neurol Scand Suppl. 2011;(191):23-7. doi: 10.1111/j.1600-0404.2011.01539.x.
PubMed 21711253Svalheim S, Luef G, Rauchenzauner M, Morkrid L, Gjerstad L, Tauboll E. Cardiovascular risk factors in epilepsy patients taking levetiracetam, carbamazepine or lamotrigine. Acta Neurol Scand Suppl. 2010;(190):30-3. doi: 10.1111/j.1600-0404.2010.01372.x.
PubMed 20586732Svalheim S, Tauboll E, Luef G, Lossius A, Rauchenzauner M, Sandvand F, Bertelsen M, Morkrid L, Gjerstad L. Differential effects of levetiracetam, carbamazepine, and lamotrigine on reproductive endocrine function in adults. Epilepsy Behav. 2009 Oct;16(2):281-7. doi: 10.1016/j.yebeh.2009.07.033. Epub 2009 Aug 27.
PubMed 19716343
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levetiracetam, Carbamazepine and Lamotrigine and Hormonal Side Effects in Adult Males and Females.
- ClinicalTrials.gov ID
- NCT00460070
- Acronym / sponsor ID
- M52332
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Rikshospitalet University HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2007
- Study completion
- Mar 2009 (actual)
- First posted
- 13 Apr 2007 (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.
Some antiepileptic drugs are found to have hormonal side effects. We want to study possible hormonal side effects of the relatively new antiepileptic drug; levetiracetam and compare it to the older drugs; lamotrigine and carbamazepine. The participants are going to fill in a questionnaire and we will collect blood samples from them, to analyse hormones.
Detailed description
We have previously performed long-term studies of rats treated with levetiracetam and compared them with a control group. Here we have found that levetiracetam has a probable effect on the ovaries, since the treated animals had larger ovaries, fewer cysts, more corpora lutea and more secondary follicles than the untreated animals (Taubøll et al 2004). Blood tests on the animals showed that those treated with levetiracetam had higher testosterone levels and lower levels of estrogen and FSH, whilst LH and progesterone levels were unaffected by the treatment (Svalheim et al, 2005a, b). Studies on cell cultures from pig ovaries, as carried out by our group in collaboration with Jagiellonian University, Krakow, Poland, appeared to support these findings (Taubøll et al. 2006, submitted).
Our wish therefore now is to study fertile men and women in order to look for any changes in the balance of sex hormones during use of levetiracetam in order to establish whether the findings in animal trials are clinically relevant to humans.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients from the outpatients clinic
Key inclusion criteria (3 listed)
- Having epilepsy
- Age 18- 45
- Using levetiracetam/ lamotrigine or carbamazepine in monotherapy for at least 6 months
Key exclusion criteria (2 listed)
- Hormonal diseases( ie; diabetes, hypo/ hyperthyroid disease)
- Use of hormonal anticonception drugs or other hormonal drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 27 Jul 2011.
- Results publication: PubMed 21711253Bachmann T, Bertheussen KH, Svalheim S, Rauchenzauner M, Luef G, Gjerstad L, Tauboll E. Haematological side effects of antiepileptic drug treatment in patients with epilepsy. Acta Neurol Scand Suppl. 2011;(191):23-7. doi: 10.1111/j.1600-0404.2011.01539.x.
- Results publication: PubMed 20586732Svalheim S, Luef G, Rauchenzauner M, Morkrid L, Gjerstad L, Tauboll E. Cardiovascular risk factors in epilepsy patients taking levetiracetam, carbamazepine or lamotrigine. Acta Neurol Scand Suppl. 2010;(190):30-3. doi: 10.1111/j.1600-0404.2010.01372.x.
- Results publication: PubMed 19716343Svalheim S, Tauboll E, Luef G, Lossius A, Rauchenzauner M, Sandvand F, Bertelsen M, Morkrid L, Gjerstad L. Differential effects of levetiracetam, carbamazepine, and lamotrigine on reproductive endocrine function in adults. Epilepsy Behav. 2009 Oct;16(2):281-7. doi: 10.1016/j.yebeh.2009.07.033. Epub 2009 Aug 27.
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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.
Erik Taubøll, MD principal investigator
unaffiliation
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 Rikshospitalet University Hospital at 1 site in Norway.
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 3 inclusion and 2 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 27 Jul 2011. 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 Norway. 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 NCT00460070, which also lists 3 linked publications.
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 27 Jul 2011.