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Hormone Profiles in Adults With Newly Diagnosed Epilepsy

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ClinicalTrials.gov Identifier: NCT00137709
Recruitment Status : Unknown
Verified October 2007 by Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : August 30, 2005
Last Update Posted : October 31, 2007
Sponsor:
Information provided by:
Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE August 30, 2005
Last Update Posted Date October 31, 2007
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
Fasting insulin/glucose ratio [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
Fasting insulin/glucose ratio.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
  • Number of subjects with above normal upper limit(s) of: insulin level [ Time Frame: 12 months ]
  • testosterone [ Time Frame: 12 months ]
  • low-density lipoprotein (LDL) cholesterol [ Time Frame: 12 months ]
  • luteinizing hormone (LH)/follicle stimulating hormone (FSH) ratio [ Time Frame: 12 months ]
  • dehydroepiandrosterone (DHEA) [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
  • Number of subjects with above normal upper limit(s) of:
  • - Insulin level
  • - Testosterone
  • - LDL cholesterol
  • - LH/FSH ratio
  • - DHEA
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hormone Profiles in Adults With Newly Diagnosed Epilepsy
Official Title  ICMJE Hormone Profiles in Adults Treated With Valproate vs. Lamotrigine Monotherapy for Newly Diagnosed Epilepsy: A Prospective Randomised Study
Brief Summary Both sodium valproate and lamotrigine are currently used in the treatment of newly diagnosed epilepsy. Although they appear to have similar efficacy, they have different side effects, which have not been well studied. This study aims to compare one particular aspect of their possible side effects, namely whether they affect certain hormonal functions.
Detailed Description

Sodium valproate is an established antiepileptic drug used against a broad range of seizure types. Lamotrigine, a newer antiepileptic drug available since late 1980s, has a similar range of action and is approved as first-line treatment for epilepsy in the United States and many European countries as well as in Hong Kong. Recently, concern has been raised over the association between valproate treatment and polycystic ovarian syndrome, a condition characterised by multiple cysts in the ovaries in women and a range of hormonal and metabolic disturbances. Cross-sectional studies from Finland suggest that up to 40% of women treated with valproate have polycystic ovaries. Lamotrigine substitution for valproate has been reported to normalise these parameters in some patients. Elevated serum insulin and androgen levels have also been reported in over 50% of male patients taking valproate for epilepsy. However, such high incidence of hormonal abnormalities associated with valproate treatment has not been reproduced in studies conducted in other western populations. No similar studies in Chinese patients have been reported. In addition, these cross-sectional studies suffer from many potential confounding factors, such as previous treatment with other antiepileptic drugs, variation in duration of treatment, thus limiting the ability to establish a causal relationship.

This phase IV study aims to examine whether valproate treatment is associated with hormonal abnormalities in Chinese epilepsy patients. Newly diagnosed patients will be randomised to receive valproate or lamotrigine and their hormonal profiles measured prospectively for 12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: Sodium valproate
    Week 1 & 2 - 200mg twice daily Week 3 onwards - 400mg twice daily
  • Drug: Lamotrigine
    Week 1 - 25mg mane Week 2 - 25mg twice daily Week 3 - 25mg mane, 50mg nocte Week 4 onwards - 50mg twice daily
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 29, 2005)
80
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged between 15 and 55
  • Ethnically Chinese
  • Newly diagnosed epilepsy requiring antiepileptic drug treatment; or patients previously treated with antiepileptic drugs but have withdrawn from medication for at least 1 year, and now require resumption of antiepileptic drug therapy due to seizure relapse.

Exclusion Criteria:

  • Post-menopausal women.
  • Pregnant women.
  • Women who have undergone oophorectomy.
  • Women taking or have taken oral contraceptive pills in the previous 3 months.
  • Women diagnosed with or suspected to have polycystic ovarian syndrome.
  • Subjects with diabetes mellitus.
  • Subjects receiving hormone replacement or glucocorticoids.
  • Subjects receiving long-term warfarin.
  • Subjects suffering from significant systemic diseases, or illnesses that interfere with pituitary-gonadal functions.
  • Subjects with a progressive or degenerative neurological disorder.
  • Subjects who are unable to take their medication reliably.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137709
Other Study ID Numbers  ICMJE CRE-2004.399
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick Kwan, FHKAM Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP