NCT00460070

Brief 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. The participants are going to fill in a questionnaire and we will collect blood samples from them, to analyse hormones.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 27, 2011

Status Verified

October 1, 2009

First QC Date

April 12, 2007

Last Update Submit

July 26, 2011

Conditions

Epilepsy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients from the outpatients clinic

You may qualify if:

  • Having epilepsy
  • Age 18- 45
  • Using levetiracetam/ lamotrigine or carbamazepine in monotherapy for at least 6 months

You may not qualify if:

  • Hormonal diseases( ie; diabetes, hypo/ hyperthyroid disease)
  • Use of hormonal anticonception drugs or other hormonal drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Neurology, Rikshospitalet Universty Hospital

Oslo, Oslo County, 0027, Norway

Location

Related Publications (3)

  • 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.

    PMID: 21711253RESULT

  • Svalheim 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.

    PMID: 20586732RESULT

  • Svalheim 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.

    PMID: 19716343RESULT

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Erik Taubøll, MD

    unaffiliation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2007

First Posted

April 13, 2007

Study Start

January 1, 2007

Study Completion

March 1, 2009

Last Updated

July 27, 2011

Record last verified: 2009-10

Locations

NO(1)