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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Sodium valproate Drug: Lamotrigine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hormone Profiles in Adults Treated With Valproate vs. Lamotrigine Monotherapy for Newly Diagnosed Epilepsy: A Prospective Randomised Study
Study Start Date : November 2004
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Hormones

Arms and Interventions
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. Fasting insulin/glucose ratio [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of subjects with above normal upper limit(s) of: insulin level [ Time Frame: 12 months ]
  2. testosterone [ Time Frame: 12 months ]
  3. low-density lipoprotein (LDL) cholesterol [ Time Frame: 12 months ]
  4. luteinizing hormone (LH)/follicle stimulating hormone (FSH) ratio [ Time Frame: 12 months ]
  5. dehydroepiandrosterone (DHEA) [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137709


Contacts
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Contact: Patrick Kwan, FHKAM 852-2632-2211 patrickkwan@cuhk.edu.hk
Contact: Evelyn Yu, MSc 852-2632-3856 evelyn.yu@cuhk.edu.hk

Locations
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Hong Kong
United Christian Hospital Recruiting
Kowloon, Hong Kong
Contact: Ping Wing Ng, FHKAM         
Principal Investigator: Ping Wing Ng, FHKAM         
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Patrick Kwan, FHKAM    852-2632-2211    patrickkwan@cuhk.edu.hk   
Contact: Evelyn Yu, MSc    852-2632-3856    evelyn.yu@cuhk.edu.hk   
Principal Investigator: Patrick Kwan, FHKAM         
Sub-Investigator: Howan Leung, MRCP         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Patrick Kwan, FHKAM Chinese University of Hong Kong
More Information
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ClinicalTrials.gov Identifier: NCT00137709    
Other Study ID Numbers: CRE-2004.399
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007
Keywords provided by Chinese University of Hong Kong:
epilepsy
hormone
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Valproic Acid
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers
Enzyme Inhibitors
GABA Agents
Neurotransmitter Agents
Antimanic Agents